145 Regulatory Affairs Manager jobs in the United Kingdom
Regulatory Affairs Manager
Witney, South East
Abbott
Posted 13 days ago
Job Viewed
Job Description
**Regulatory Affairs Manager**
**Abbott Diabetes Care**
**Witney, Oxfordshire**
**Competitive Salary + Excellent Benefits**
Abbott Diabetes Care designs, develops and manufactures leading-edge glucose monitoring systems and test strips for use in both home and hospital settings. Our product portfolio includes Freestyle Libre, a recently launched system that is revolutionising how people with diabetes around the world monitor their glucose levels. We are passionate about doing work that improves the quality of people's lives.
We currently have an opportunity for a Regulatory Affairs Manager to join our team, based in Oxfordshire, supporting the significant manufacturing capacity expansion underway at the Witney site plus other Operational and R&D projects.
**Primary Job Function**
You will set the EU Regulatory Strategy that is well-defined and effective. The strategy sets out innovative solutions to Regulatory Approval so that plans can be set out.
You will oversee the Project Management of regulatory projects, integrating with the US and OUS Regulatory organisation, the R&D organisation and other key functional groups.
**Core Job Responsibilities**
+ Ensures maintenance of strong communication and working relationships with the Alameda RA group and other RA teams globally.
+ Ensures maintenance of strong communication and working relationships with the Clinical Affairs organisation, R&D Development groups and US Project Management.
+ Supports the interface and guidance of any external auditors such as FDA and ISO assessors reviewing Technical Files.
+ Provides leadership on Notified Body strategy and regional/global planning of product registration.
+ Responsible for defining the regulatory strategy for product approvals in EU and region.
+ Each new development project (product) requires a regulatory strategy to be created and maintained.
+ Responsible for supporting RA compliance with site EHS policy and procedures.
+ Responsible for maintaining the effectiveness of the Quality System at the site in accordance with Abbott Corporate requirements and applicable regulations.
+ Excellent communication / negotiating skills for discussions with Notified Bodies and Competent Authorities etc.
**Position Accountability / Scope**
+ Responsible for ensuring that products designed, changed or purchased by ADC in Europe meet the quality and regulatory standards as required by regulatory, quality, Abbott Corporate and national requirements.
+ This position must ensure that the products are registered in the countries as appropriate and ensure compliance to QS Regulations, ISO regulations, etc.
+ Responsible for ensuring that products designed, changed or purchased by ADC in Europe meet the quality and regulatory standards as required by regulatory, quality, Abbott Corporate and national requirements.
**Minimum** **Education**
+ Minimum of a Bachelor's degree or equivalent preferably in a Scientific discipline e.g. Chemistry, life Sciences, Biology.
**Minimum** **Experience/Training Required**
+ Minimum of a bachelor's degree is required to ensure that the jobholder has sufficient technical knowledge to effectively and confidently be the Regulatory Affairs Project Mgr in the EMEA region.
+ Knowledge of regulatory requirements for ISO 13485, EMC, MDD (93/42/EEC), IVDD (98/79/EC), MDR 2017/745 & IVDR 2017/756, and FDA Quality Systems Regulations is essential.
+ Experience within a medical or healthcare manufacturing industry in a regulatory role. The position requires an understanding of the needs of the customer and knowledge of regulations and standards affecting IVDs and MDDs, the regulatory bodies and country regulations that govern ADC products to enable the jobholder to interpret and apply regulations and standards to products and processes.
+ You need to have excellent written and oral communication skills necessary to be able to produce succinct reports and documentation and to effectively communicate with other departments, managers and external regulatory organizations.
+ You need to have the depth of Regulatory knowledge to be able to define a Regulatory Strategy that is well defined and effective. Additionally, the depth of experience is required to ensure that innovative solutions to Regulatory Approval paths can be set out.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
**Abbott Diabetes Care**
**Witney, Oxfordshire**
**Competitive Salary + Excellent Benefits**
Abbott Diabetes Care designs, develops and manufactures leading-edge glucose monitoring systems and test strips for use in both home and hospital settings. Our product portfolio includes Freestyle Libre, a recently launched system that is revolutionising how people with diabetes around the world monitor their glucose levels. We are passionate about doing work that improves the quality of people's lives.
We currently have an opportunity for a Regulatory Affairs Manager to join our team, based in Oxfordshire, supporting the significant manufacturing capacity expansion underway at the Witney site plus other Operational and R&D projects.
**Primary Job Function**
You will set the EU Regulatory Strategy that is well-defined and effective. The strategy sets out innovative solutions to Regulatory Approval so that plans can be set out.
You will oversee the Project Management of regulatory projects, integrating with the US and OUS Regulatory organisation, the R&D organisation and other key functional groups.
**Core Job Responsibilities**
+ Ensures maintenance of strong communication and working relationships with the Alameda RA group and other RA teams globally.
+ Ensures maintenance of strong communication and working relationships with the Clinical Affairs organisation, R&D Development groups and US Project Management.
+ Supports the interface and guidance of any external auditors such as FDA and ISO assessors reviewing Technical Files.
+ Provides leadership on Notified Body strategy and regional/global planning of product registration.
+ Responsible for defining the regulatory strategy for product approvals in EU and region.
+ Each new development project (product) requires a regulatory strategy to be created and maintained.
+ Responsible for supporting RA compliance with site EHS policy and procedures.
+ Responsible for maintaining the effectiveness of the Quality System at the site in accordance with Abbott Corporate requirements and applicable regulations.
+ Excellent communication / negotiating skills for discussions with Notified Bodies and Competent Authorities etc.
**Position Accountability / Scope**
+ Responsible for ensuring that products designed, changed or purchased by ADC in Europe meet the quality and regulatory standards as required by regulatory, quality, Abbott Corporate and national requirements.
+ This position must ensure that the products are registered in the countries as appropriate and ensure compliance to QS Regulations, ISO regulations, etc.
+ Responsible for ensuring that products designed, changed or purchased by ADC in Europe meet the quality and regulatory standards as required by regulatory, quality, Abbott Corporate and national requirements.
**Minimum** **Education**
+ Minimum of a Bachelor's degree or equivalent preferably in a Scientific discipline e.g. Chemistry, life Sciences, Biology.
**Minimum** **Experience/Training Required**
+ Minimum of a bachelor's degree is required to ensure that the jobholder has sufficient technical knowledge to effectively and confidently be the Regulatory Affairs Project Mgr in the EMEA region.
+ Knowledge of regulatory requirements for ISO 13485, EMC, MDD (93/42/EEC), IVDD (98/79/EC), MDR 2017/745 & IVDR 2017/756, and FDA Quality Systems Regulations is essential.
+ Experience within a medical or healthcare manufacturing industry in a regulatory role. The position requires an understanding of the needs of the customer and knowledge of regulations and standards affecting IVDs and MDDs, the regulatory bodies and country regulations that govern ADC products to enable the jobholder to interpret and apply regulations and standards to products and processes.
+ You need to have excellent written and oral communication skills necessary to be able to produce succinct reports and documentation and to effectively communicate with other departments, managers and external regulatory organizations.
+ You need to have the depth of Regulatory knowledge to be able to define a Regulatory Strategy that is well defined and effective. Additionally, the depth of experience is required to ensure that innovative solutions to Regulatory Approval paths can be set out.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
This advertiser has chosen not to accept applicants from your region.
0
Regulatory Affairs Manager (EMEA)
Bausch Health
Posted 6 days ago
Job Viewed
Job Description
Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates itwhere your skills and values drive our collective progress and impact.
The Regulatory Affairs Manager (EMEA) is going to provide direct support to Solta operations for their globally distributed products. They work closely with global regulatory affairs peers, Quality, R&D, Operations to support EMEA licensing and registrations, and to ensure the effective execution and management of changes. In addition, Working as the primary contact for EMEA regulatory intelligence for the regulatory department.
This role may also serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of EU MDR, ensuring regulatory obligations are fulfilled in accordance with applicable requirements.The key responsibilities include, but are not limited to:
**Responsibilities**
+ Collaborating with Soltas global regulatory teams in developing regulatory strategies for new product launch and obtain regional product approvals timely for EMEA markets.
+ Work as the primary contact for EMEA regulatory intelligence, proactively search and monitor policy, regulation, guidance and standard changes from health authorities, lead cross functions to analyze the impact of regulatory environment changes to the companys products and business, and update to key stakeholders timely.
+ Summarize and provide regional regulatory intelligence report periodically.
+ Coordinate and lead the interaction with regional authorities and Notified Bodies.
+ Play a key role in interpreting regional regulations, standards, guidance, and registration requirement, provide regulatory guidance to and work closely with Soltas global regulatory affairs team.
+ Provide regulatory input and assessment for new product introduction (NPI) and maintenance of business (MOB) projects.
+ Manage & monitor the performance of EMEA registration agencies and local distributors in terms of compliance.
+ Create and maintain local regulatory related databases including but not limited to EUDAMED etc.
+ Review and approve advertising, promotional materials and labeling to ensure regulatory compliance.
+ Represent regional RA to participate in the draft and maintenance of global and local RA related SOPs/WIs.
+ Provide strong support to commercial, supply chain, QA team etc.
+ Support internal and external audits/inspections as required.
+ Ensure the conformity of devices is appropriately checked before release, and that technical documentation and declarations of conformity are properly maintained.
+ Oversee post-market surveillance activities and ensure reporting obligations under Articles 8791 of MDR are fulfilled.
+ Perform other duties as assigned.
**The minimum requirements:**
+ Bachelor degree or above in engineering, life science, or mechanical discipline;
+ Minimum 6-8 years regulatory affairs experience in MNC, regulatory knowledge of other country and region is a plus ;
+ Meets the qualification criteria to act as PRRC under Article 15 of MDR: either a university degree in a relevant field with at least 1 year of regulatory experience, or 4 years of professional experience in regulatory affairs or quality management systems related to medical devices.
+ Strong technical skills associated with active medical devices, in-depth understanding of EU MDR, experience of laser, RF or ultrasound device registration is a plus, aesthetic device is a plus;
+ Expertise and experience in regulatory intelligence, Regulatory database management including but not limited to EUDAMED etc.;
+ Good interpersonal skills, team player with the ability to work independently in a fast-paced and dynamic environment.
+ Fluency in written and spoken English.
#LI-REMOTE
We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.
The Regulatory Affairs Manager (EMEA) is going to provide direct support to Solta operations for their globally distributed products. They work closely with global regulatory affairs peers, Quality, R&D, Operations to support EMEA licensing and registrations, and to ensure the effective execution and management of changes. In addition, Working as the primary contact for EMEA regulatory intelligence for the regulatory department.
This role may also serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of EU MDR, ensuring regulatory obligations are fulfilled in accordance with applicable requirements.The key responsibilities include, but are not limited to:
**Responsibilities**
+ Collaborating with Soltas global regulatory teams in developing regulatory strategies for new product launch and obtain regional product approvals timely for EMEA markets.
+ Work as the primary contact for EMEA regulatory intelligence, proactively search and monitor policy, regulation, guidance and standard changes from health authorities, lead cross functions to analyze the impact of regulatory environment changes to the companys products and business, and update to key stakeholders timely.
+ Summarize and provide regional regulatory intelligence report periodically.
+ Coordinate and lead the interaction with regional authorities and Notified Bodies.
+ Play a key role in interpreting regional regulations, standards, guidance, and registration requirement, provide regulatory guidance to and work closely with Soltas global regulatory affairs team.
+ Provide regulatory input and assessment for new product introduction (NPI) and maintenance of business (MOB) projects.
+ Manage & monitor the performance of EMEA registration agencies and local distributors in terms of compliance.
+ Create and maintain local regulatory related databases including but not limited to EUDAMED etc.
+ Review and approve advertising, promotional materials and labeling to ensure regulatory compliance.
+ Represent regional RA to participate in the draft and maintenance of global and local RA related SOPs/WIs.
+ Provide strong support to commercial, supply chain, QA team etc.
+ Support internal and external audits/inspections as required.
+ Ensure the conformity of devices is appropriately checked before release, and that technical documentation and declarations of conformity are properly maintained.
+ Oversee post-market surveillance activities and ensure reporting obligations under Articles 8791 of MDR are fulfilled.
+ Perform other duties as assigned.
**The minimum requirements:**
+ Bachelor degree or above in engineering, life science, or mechanical discipline;
+ Minimum 6-8 years regulatory affairs experience in MNC, regulatory knowledge of other country and region is a plus ;
+ Meets the qualification criteria to act as PRRC under Article 15 of MDR: either a university degree in a relevant field with at least 1 year of regulatory experience, or 4 years of professional experience in regulatory affairs or quality management systems related to medical devices.
+ Strong technical skills associated with active medical devices, in-depth understanding of EU MDR, experience of laser, RF or ultrasound device registration is a plus, aesthetic device is a plus;
+ Expertise and experience in regulatory intelligence, Regulatory database management including but not limited to EUDAMED etc.;
+ Good interpersonal skills, team player with the ability to work independently in a fast-paced and dynamic environment.
+ Fluency in written and spoken English.
#LI-REMOTE
We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.
This advertiser has chosen not to accept applicants from your region.
1
Pharmaceutical Regulatory Affairs Manager
CV1 2DT Coventry, West Midlands
£75000 Annually
WhatJobs
Posted 10 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking an experienced Pharmaceutical Regulatory Affairs Manager to join their team. This hybrid role, based in Coventry, West Midlands, UK , offers the chance to play a pivotal role in ensuring compliance with regulatory requirements for drug development and marketing. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and providing strategic regulatory guidance throughout the product lifecycle. The ideal candidate will possess a strong understanding of global pharmaceutical regulations and a proven ability to navigate complex regulatory landscapes.
Key Responsibilities:
Key Responsibilities:
- Develop and execute global regulatory strategies for assigned pharmaceutical products.
- Prepare, review, and submit regulatory submissions (e.g., INDs, NDAs, MAAs) to health authorities worldwide.
- Serve as the primary point of contact with regulatory agencies, managing communications and responding to queries.
- Ensure that all regulatory activities comply with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and other relevant regulations.
- Provide regulatory guidance and support to internal teams, including R&D, clinical operations, manufacturing, and marketing.
- Assess the regulatory impact of proposed changes to products, processes, or labeling.
- Stay current with evolving global regulatory requirements and guidelines, and advise the company accordingly.
- Manage and maintain regulatory databases and documentation systems.
- Lead regulatory interactions and inspections with health authorities.
- Contribute to the development of regulatory policies and procedures within the company.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field; a Master's or PhD is highly desirable.
- A minimum of 7 years of experience in pharmaceutical regulatory affairs.
- Demonstrated experience in preparing and submitting successful regulatory dossiers to major health authorities (e.g., FDA, EMA).
- In-depth knowledge of pharmaceutical drug development processes and regulatory frameworks.
- Excellent understanding of cGMP, GCP, and ICH guidelines.
- Strong analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with the ability to present complex information clearly.
- Proven ability to manage multiple projects and prioritize effectively in a fast-paced environment.
- Experience working in a hybrid model, balancing remote and in-office responsibilities.
- Strong negotiation and influencing skills.
This advertiser has chosen not to accept applicants from your region.
2
Senior Regulatory Affairs Manager - Pharmaceuticals
WV1 1DJ Wolverhampton, West Midlands
£70000 Annually
WhatJobs
Posted 1 day ago
Job Viewed
Job Description
Our client, a rapidly expanding pharmaceutical company dedicated to developing life-changing therapies, is seeking a highly experienced Senior Regulatory Affairs Manager to join their team in **Wolverhampton, West Midlands, UK**. This critical role requires a deep understanding of global regulatory landscapes and a proven ability to navigate complex submission processes. You will be instrumental in ensuring compliance with regulatory requirements for product development, manufacturing, and marketing across key international markets. The ideal candidate is a meticulous planner, a strategic thinker, and an exceptional communicator, capable of liaising effectively with health authorities and internal stakeholders. Responsibilities include:
- Developing and implementing global regulatory strategies for product development programs, ensuring alignment with business objectives.
- Preparing, compiling, and submitting regulatory documentation (e.g., INDs, NDAs, MAAs, variations) to health authorities worldwide.
- Serving as the primary point of contact with regulatory agencies, managing correspondence and addressing queries.
- Interpreting and advising on the impact of evolving regulatory guidelines and requirements on product development and lifecycle management.
- Collaborating closely with cross-functional teams, including R&D, clinical affairs, manufacturing, and quality assurance, to ensure regulatory compliance.
- Reviewing and approving promotional materials, labeling, and advertising to ensure compliance with relevant regulations.
- Conducting regulatory due diligence for potential partnerships, acquisitions, and licensing opportunities.
- Managing post-approval regulatory activities, including annual reports, supplements, and change controls.
- Mentoring and developing junior regulatory affairs professionals.
- Staying current with industry best practices and emerging regulatory trends.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. A Master's degree or Pharm.D. is preferred.
- Minimum of 8 years of progressive experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Proven track record of successful submissions and approvals in major global markets (e.g., FDA, EMA, MHRA).
- In-depth knowledge of ICH guidelines, GMP, GCP, and GLP.
- Experience with a wide range of pharmaceutical product types (e.g., small molecules, biologics).
- Excellent strategic thinking, problem-solving, and decision-making skills.
- Exceptional written and verbal communication skills, with strong negotiation and influencing abilities.
- Ability to manage multiple complex projects simultaneously in a deadline-driven environment.
- Strong leadership skills and experience in managing teams.
- Proficiency in regulatory information management systems is an asset.
This advertiser has chosen not to accept applicants from your region.
3
Senior Pharmaceutical Regulatory Affairs Manager
BS8 4 Bristol, South West
£70000 Annually
WhatJobs
Posted 3 days ago
Job Viewed
Job Description
A leading pharmaceutical company is seeking an experienced Senior Pharmaceutical Regulatory Affairs Manager to join their dedicated team. This is a fully remote position, offering the flexibility to work from home across the UK. You will be responsible for ensuring compliance with regulatory requirements for drug development and submissions, playing a crucial role in bringing life-changing therapies to market.
Responsibilities:
Responsibilities:
- Develop and execute regulatory strategies for product development, registration, and lifecycle management in key global markets.
- Prepare, review, and submit regulatory dossiers (e.g., CTD, IND, NDA) to health authorities worldwide.
- Liaise directly with regulatory agencies (e.g., EMA, FDA) to facilitate communication and address queries.
- Provide expert regulatory guidance to cross-functional teams, including R&D, clinical operations, and manufacturing.
- Stay abreast of evolving regulatory landscapes, guidelines, and best practices.
- Assess the regulatory implications of product changes and lifecycle management activities.
- Manage and maintain regulatory compliance documentation and systems.
- Lead and mentor junior regulatory affairs professionals.
- Participate in regulatory intelligence gathering and risk assessment activities.
- Contribute to the development of departmental SOPs and processes.
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global pharmaceutical regulations (e.g., ICH guidelines, FDA, EMA requirements).
- Proven experience in preparing and submitting successful marketing authorization applications.
- Excellent understanding of drug development processes from preclinical to post-marketing.
- Strong analytical, problem-solving, and strategic thinking skills.
- Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
- Ability to manage multiple projects and meet tight deadlines.
- Proficiency in regulatory information management systems is a plus.
- Demonstrated ability to work effectively in a fully remote, collaborative environment.
This advertiser has chosen not to accept applicants from your region.
4
Senior Pharmaceutical Regulatory Affairs Manager
BS1 1AA Bristol, South West
£85000 Annually
WhatJobs
Posted 7 days ago
Job Viewed
Job Description
Our client, a distinguished leader in the pharmaceutical industry, is seeking an experienced Senior Pharmaceutical Regulatory Affairs Manager to join their esteemed team in Bristol, South West England, UK . This critical role involves overseeing and managing all aspects of regulatory affairs for pharmaceutical products, ensuring compliance with national and international regulations. You will be instrumental in developing and implementing regulatory strategies to facilitate the successful registration and lifecycle management of innovative drug products.
The ideal candidate will possess a deep understanding of pharmaceutical development, regulatory submission processes (e.g., IND, NDA, MAA), and guidelines set forth by major health authorities such as the FDA, EMA, and MHRA. You will lead a team of regulatory affairs professionals, providing guidance and mentorship while fostering a culture of excellence and compliance. Responsibilities include preparing, reviewing, and submitting regulatory documentation, liaising with regulatory agencies, and advising project teams on regulatory requirements and potential challenges. You will also stay abreast of evolving regulatory landscapes and contribute to the company's strategic planning. This role requires exceptional communication, negotiation, and strategic thinking skills, with a proven ability to manage complex projects and drive successful regulatory outcomes.
Key Responsibilities:
Qualifications:
The ideal candidate will possess a deep understanding of pharmaceutical development, regulatory submission processes (e.g., IND, NDA, MAA), and guidelines set forth by major health authorities such as the FDA, EMA, and MHRA. You will lead a team of regulatory affairs professionals, providing guidance and mentorship while fostering a culture of excellence and compliance. Responsibilities include preparing, reviewing, and submitting regulatory documentation, liaising with regulatory agencies, and advising project teams on regulatory requirements and potential challenges. You will also stay abreast of evolving regulatory landscapes and contribute to the company's strategic planning. This role requires exceptional communication, negotiation, and strategic thinking skills, with a proven ability to manage complex projects and drive successful regulatory outcomes.
Key Responsibilities:
- Develop and execute regulatory affairs strategies for pharmaceutical products.
- Prepare, review, and submit regulatory dossiers to health authorities globally.
- Serve as the primary point of contact with regulatory agencies.
- Provide strategic regulatory guidance to R&D, clinical, and commercial teams.
- Ensure ongoing compliance with all applicable regulations and guidelines.
- Manage the lifecycle of regulatory submissions, including variations and annual reports.
- Lead and mentor a team of regulatory affairs professionals.
- Conduct regulatory intelligence activities to stay informed of changes in the regulatory environment.
- Assess the regulatory impact of proposed development plans and clinical study designs.
- Contribute to regulatory policy development and advocacy efforts.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field; advanced degree preferred.
- Minimum of 7-10 years of experience in pharmaceutical regulatory affairs.
- Extensive knowledge of global pharmaceutical regulations and submission pathways.
- Proven experience in preparing and submitting successful regulatory dossiers.
- Strong understanding of drug development processes from pre-clinical to post-marketing.
- Excellent communication, interpersonal, and negotiation skills.
- Demonstrated leadership and team management abilities.
- Ability to work independently and manage multiple complex projects simultaneously.
- Proficiency in regulatory information management systems is a plus.
This advertiser has chosen not to accept applicants from your region.
5
Senior Regulatory Affairs Manager - Pharmaceuticals
MK1 1FF Milton Keynes, South East
£75000 Annually
WhatJobs
Posted 12 days ago
Job Viewed
Job Description
Our client, a rapidly expanding pharmaceutical company dedicated to developing innovative therapeutics, is seeking a highly experienced Senior Regulatory Affairs Manager to join their esteemed team in Milton Keynes, Buckinghamshire, UK . This crucial role will oversee the regulatory strategy for key product pipelines, ensuring compliance with global health authority regulations and facilitating the timely submission and approval of new drug applications. The ideal candidate will possess extensive knowledge of pharmaceutical regulatory affairs, exceptional leadership skills, and a proven track record in navigating complex regulatory landscapes.
Key Responsibilities:
Key Responsibilities:
- Develop and implement global regulatory strategies for product development, registration, and lifecycle management.
- Lead the preparation and submission of regulatory dossiers (e.g., INDs, NDAs, MAAs) to various health authorities (FDA, EMA, MHRA, etc.).
- Serve as the primary regulatory contact with health authorities and manage all communications and interactions.
- Provide strategic regulatory guidance to cross-functional teams, including R&D, Clinical Operations, Quality Assurance, and Commercial.
- Monitor and interpret evolving regulatory guidelines and advise the organization on their impact.
- Ensure that all regulatory activities are conducted in compliance with company policies and relevant regulations.
- Manage the regulatory aspects of product lifecycle management, including post-approval variations and renewals.
- Review and approve regulatory labeling, promotional materials, and other regulated communications.
- Conduct due diligence for potential partnerships and acquisitions from a regulatory perspective.
- Mentor and develop junior members of the regulatory affairs team.
- Contribute to the development and refinement of departmental SOPs and processes.
- Advanced degree (MSc, PhD, PharmD) in a relevant scientific or healthcare discipline.
- Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
- Demonstrated success in preparing and submitting successful regulatory dossiers to major health authorities.
- In-depth knowledge of global regulatory requirements for drug development and marketing authorization.
- Experience with various therapeutic areas is advantageous.
- Strong leadership, project management, and strategic thinking skills.
- Excellent written and verbal communication skills, with a keen eye for detail.
- Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities.
- Proficiency in regulatory information management systems is a plus.
- Strong understanding of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Regulatory affairs manager Jobs in United Kingdom !
6
Senior Pharmaceutical Regulatory Affairs Manager
NR1 1AA Norwich, Eastern
£70000 Annually
WhatJobs
Posted 15 days ago
Job Viewed
Job Description
Our client, a leading biopharmaceutical company dedicated to discovering, developing, and commercializing innovative medicines, is seeking an experienced Senior Pharmaceutical Regulatory Affairs Manager to join their team in **Norwich, Norfolk, UK**. This is a critical role responsible for guiding drug products through the complex regulatory landscape, ensuring compliance and timely approvals in key global markets.
The successful candidate will manage regulatory submission strategies, prepare and review regulatory documents, and liaise with health authorities worldwide. You will provide expert guidance on regulatory requirements, policies, and procedures throughout the product lifecycle, from early development to post-marketing surveillance. This hybrid role offers a flexible working arrangement, balancing essential on-site collaboration with the autonomy of remote work. You will be instrumental in shaping regulatory strategies, contributing to the company's pipeline advancement and ultimately, making a difference in patient lives. This position requires a meticulous, detail-oriented professional with a strong understanding of pharmaceutical development and regulatory affairs.
Key Responsibilities:
The successful candidate will manage regulatory submission strategies, prepare and review regulatory documents, and liaise with health authorities worldwide. You will provide expert guidance on regulatory requirements, policies, and procedures throughout the product lifecycle, from early development to post-marketing surveillance. This hybrid role offers a flexible working arrangement, balancing essential on-site collaboration with the autonomy of remote work. You will be instrumental in shaping regulatory strategies, contributing to the company's pipeline advancement and ultimately, making a difference in patient lives. This position requires a meticulous, detail-oriented professional with a strong understanding of pharmaceutical development and regulatory affairs.
Key Responsibilities:
- Develop and implement global regulatory strategies for pharmaceutical products.
- Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs, variations) to health authorities (FDA, EMA, MHRA, etc.).
- Liaise effectively with regulatory agencies to facilitate approvals and address queries.
- Provide regulatory guidance and interpretation of guidelines to project teams.
- Assess the regulatory implications of proposed product changes and development plans.
- Manage and maintain regulatory compliance for assigned products.
- Monitor changes in the regulatory environment and advise the company accordingly.
- Review and approve promotional materials and labelling for regulatory compliance.
- Collaborate with cross-functional teams, including R&D, clinical operations, manufacturing, and quality assurance.
- Lead regulatory aspects of due diligence activities for potential business development opportunities.
- Ensure that all regulatory activities are conducted in accordance with company policies and SOPs.
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field. Advanced degree (e.g., PhD, PharmD) is a plus.
- Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global regulatory requirements and guidelines (e.g., ICH, FDA, EMA).
- Proven experience in preparing and managing successful regulatory submissions.
- Strong understanding of drug development processes, from pre-clinical to post-marketing.
- Excellent written and verbal communication skills, with strong attention to detail.
- Ability to work effectively in a cross-functional team environment.
- Experience with hybrid work models and strong remote working capabilities.
- Project management skills and the ability to manage multiple priorities.
- Problem-solving skills and a strategic mindset.
This advertiser has chosen not to accept applicants from your region.
7
Senior Pharmaceutical Regulatory Affairs Manager
PL1 1RR Plymouth, South West
£80000 Annually
WhatJobs
Posted 21 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company dedicated to improving global health, is seeking a Senior Pharmaceutical Regulatory Affairs Manager to join their remote-based team. This pivotal role will oversee the regulatory strategy and submission process for a diverse portfolio of pharmaceutical products. You will be responsible for ensuring compliance with global regulatory requirements, guiding product development teams, and securing timely approvals from health authorities worldwide. Key responsibilities include developing and implementing regulatory strategies for product registration and lifecycle management; preparing and submitting regulatory dossiers (e.g., INDs, NDAs, MAAs) to various health agencies (e.g., FDA, EMA); serving as the primary point of contact with regulatory authorities; interpreting and advising on complex regulatory guidelines and policies; conducting regulatory intelligence activities to stay ahead of evolving requirements; managing post-approval changes and submissions; collaborating with R&D, clinical, manufacturing, and quality assurance departments; and mentoring junior regulatory affairs professionals. The ideal candidate will possess extensive experience in pharmaceutical regulatory affairs, with a deep understanding of global regulatory frameworks. Proven success in leading regulatory submissions and interactions with health authorities is essential. Excellent communication, analytical, and problem-solving skills are critical for this complex, remote role. You will be empowered to make critical decisions and contribute significantly to bringing life-saving medicines to market. Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
- Minimum of 7 years of experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions (e.g., IND, NDA, MAA) to major health authorities.
- In-depth knowledge of ICH guidelines and regional regulatory requirements.
- Experience in regulatory strategy development and lifecycle management.
- Excellent written and verbal communication skills.
- Strong analytical and critical thinking abilities.
- Ability to manage multiple projects and work effectively in a remote environment.
This advertiser has chosen not to accept applicants from your region.
8
Senior Pharmaceutical Regulatory Affairs Manager (Remote)
RG1 1DB Reading, South East
£70000 Annually
WhatJobs
Posted 4 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Manager to lead regulatory strategy and submissions. This critical, fully remote role involves ensuring compliance with global regulatory requirements and facilitating the timely approval of new pharmaceutical products. You will be a key advisor on all regulatory matters.
Responsibilities:
Qualifications:
This is a unique opportunity for a seasoned regulatory professional to make a significant impact on global health by ensuring access to safe and effective medicines. The fully remote nature of this role offers excellent work-life balance and the flexibility to contribute from anywhere in the UK. You will be working with a dedicated team committed to scientific excellence and patient well-being. If you possess a deep understanding of pharmaceutical regulations and a passion for driving regulatory success, we encourage you to apply and join our innovative organisation.
Responsibilities:
- Develop and implement global regulatory strategies for pharmaceutical product development and lifecycle management.
- Prepare, review, and submit regulatory dossiers to health authorities (e.g., EMA, FDA) in accordance with ICH guidelines and regional requirements.
- Provide regulatory guidance and interpretation of regulations to project teams, R&D, and commercial departments.
- Liaise directly with regulatory agencies to facilitate communication and address queries.
- Assess the regulatory impact of proposed changes to products and manufacturing processes.
- Manage regulatory submissions for variations, renewals, and post-approval changes.
- Monitor changes in the regulatory landscape and advise the organisation on necessary adaptations.
- Contribute to the development of regulatory policies and procedures.
- Oversee regulatory compliance activities, ensuring adherence to Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Pharmacovigilance Practice (GVP).
- Mentor and guide junior regulatory affairs professionals.
- Lead cross-functional teams in regulatory strategy development and submission preparation.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science discipline. A PhD is advantageous.
- Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
- Demonstrated success in preparing and managing regulatory submissions (e.g., CTAs, MAAs, NDAs).
- In-depth knowledge of global pharmaceutical regulations and guidelines (e.g., ICH, EMA, FDA).
- Strong understanding of drug development processes, from pre-clinical to post-market.
- Excellent written and verbal communication skills, with a keen eye for detail.
- Proven ability to manage complex projects and work effectively in a cross-functional, remote team environment.
- Strong analytical and problem-solving skills.
- Experience in specific therapeutic areas is a plus.
- Ability to influence and build strong relationships with internal stakeholders and external regulatory authorities.
This is a unique opportunity for a seasoned regulatory professional to make a significant impact on global health by ensuring access to safe and effective medicines. The fully remote nature of this role offers excellent work-life balance and the flexibility to contribute from anywhere in the UK. You will be working with a dedicated team committed to scientific excellence and patient well-being. If you possess a deep understanding of pharmaceutical regulations and a passion for driving regulatory success, we encourage you to apply and join our innovative organisation.
This advertiser has chosen not to accept applicants from your region.
9