133 Regulatory Submissions jobs in the United Kingdom
Pharmaceutical Regulatory Affairs Specialist
DE1 0BB Derby, East Midlands
£55000 Annually
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Our client, a leading pharmaceutical innovator, is seeking a highly diligent and knowledgeable Pharmaceutical Regulatory Affairs Specialist. This is an on-site position located in the heart of Derby, Derbyshire, UK . In this critical role, you will be responsible for ensuring that our pharmaceutical products comply with all national and international regulatory requirements throughout their lifecycle. Your expertise will be vital in preparing and submitting regulatory documentation, liaising with health authorities, and staying ahead of evolving regulatory landscapes. This role demands a thorough understanding of drug development processes, regulatory submission pathways, and quality compliance.
Key responsibilities include:
The ideal candidate will hold a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science discipline, with a minimum of 5 years of experience in pharmaceutical regulatory affairs. A proven track record of successful regulatory submissions and strong knowledge of regulatory submission processes and documentation requirements are essential. Familiarity with global regulatory frameworks (e.g., ICH, FDA, EMA) is highly desirable. Excellent written and verbal communication skills, strong attention to detail, and robust analytical and problem-solving abilities are paramount. This role requires a proactive and organized approach to managing complex regulatory projects. A commitment to working on-site is necessary for this position.
Key responsibilities include:
- Preparing, reviewing, and submitting regulatory dossiers (e.g., CTD, IND, NDA) to health authorities such as the MHRA, EMA, and FDA.
- Ensuring compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP).
- Monitoring and interpreting new and existing pharmaceutical regulations, guidelines, and standards.
- Providing regulatory guidance and support to internal teams, including R&D, manufacturing, and quality assurance.
- Managing the lifecycle of approved products, including post-approval variations and renewals.
- Responding to queries from regulatory agencies and coordinating meetings with health authorities.
- Developing and maintaining regulatory strategy for new product development and lifecycle management.
- Conducting regulatory intelligence activities to identify emerging trends and assess their impact.
- Ensuring timely updates to product labeling and core data sheets.
- Collaborating with cross-functional teams to ensure regulatory compliance across all company operations.
The ideal candidate will hold a Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science discipline, with a minimum of 5 years of experience in pharmaceutical regulatory affairs. A proven track record of successful regulatory submissions and strong knowledge of regulatory submission processes and documentation requirements are essential. Familiarity with global regulatory frameworks (e.g., ICH, FDA, EMA) is highly desirable. Excellent written and verbal communication skills, strong attention to detail, and robust analytical and problem-solving abilities are paramount. This role requires a proactive and organized approach to managing complex regulatory projects. A commitment to working on-site is necessary for this position.
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0
Pharmaceutical Regulatory Affairs Manager
B1 1AA Birmingham, West Midlands
£65000 Annually
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Our client, a dynamic and growing pharmaceutical company, is seeking a dedicated and experienced Pharmaceutical Regulatory Affairs Manager to oversee regulatory compliance and submissions. This key position, based in Birmingham, West Midlands, UK , will ensure that all company products meet the rigorous standards set by national and international health authorities.
As the Regulatory Affairs Manager, you will be responsible for developing and implementing regulatory strategies for new and existing pharmaceutical products. This includes preparing, reviewing, and submitting regulatory documentation such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), and variations to existing marketing authorizations. You will stay abreast of evolving regulatory landscapes, guidances, and legislation, providing expert advice to internal teams on compliance matters. Key responsibilities involve liaising with regulatory agencies, managing post-approval commitments, and ensuring the accuracy and integrity of all regulatory submissions. You will also contribute to the development of labelling and promotional materials to ensure compliance.
The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related discipline, with a minimum of 5 years of progressive experience in pharmaceutical regulatory affairs. A thorough understanding of global regulatory requirements (e.g., FDA, EMA, MHRA) and experience with dossier preparation and submission processes are essential. Strong analytical, communication, and project management skills are required, as is the ability to work effectively in a multidisciplinary team. Experience in specific therapeutic areas may be advantageous. This is an excellent opportunity for a seasoned professional to contribute to the success of a forward-thinking pharmaceutical organization in Birmingham, West Midlands, UK .
As the Regulatory Affairs Manager, you will be responsible for developing and implementing regulatory strategies for new and existing pharmaceutical products. This includes preparing, reviewing, and submitting regulatory documentation such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), and variations to existing marketing authorizations. You will stay abreast of evolving regulatory landscapes, guidances, and legislation, providing expert advice to internal teams on compliance matters. Key responsibilities involve liaising with regulatory agencies, managing post-approval commitments, and ensuring the accuracy and integrity of all regulatory submissions. You will also contribute to the development of labelling and promotional materials to ensure compliance.
The ideal candidate will possess a Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related discipline, with a minimum of 5 years of progressive experience in pharmaceutical regulatory affairs. A thorough understanding of global regulatory requirements (e.g., FDA, EMA, MHRA) and experience with dossier preparation and submission processes are essential. Strong analytical, communication, and project management skills are required, as is the ability to work effectively in a multidisciplinary team. Experience in specific therapeutic areas may be advantageous. This is an excellent opportunity for a seasoned professional to contribute to the success of a forward-thinking pharmaceutical organization in Birmingham, West Midlands, UK .
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Pharmaceutical Regulatory Affairs Specialist
NR1 1AA Norwich, Eastern
£55000 Annually
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Our client is a leading pharmaceutical company seeking a highly skilled and experienced Pharmaceutical Regulatory Affairs Specialist to join their dedicated team. This role is based in **Norwich, Norfolk, UK**, and requires the individual to work on-site. You will play a critical role in ensuring compliance with all relevant national and international regulatory requirements for drug development, manufacturing, and marketing. This involves preparing and submitting regulatory documentation, liaising with health authorities, and staying current with evolving regulations.
Key Responsibilities:
Qualifications and Experience:
This is a vital role within our client's organization, offering the chance to contribute significantly to bringing life-saving medicines to patients. If you possess the required expertise and are looking for a challenging and rewarding career, we encourage you to apply.
Key Responsibilities:
- Prepare, review, and submit regulatory documentation for clinical trial applications (CTAs), marketing authorization applications (MAAs), and variations in accordance with ICH and regional guidelines.
- Act as a key point of contact with regulatory agencies (e.g., MHRA, EMA, FDA) for assigned projects.
- Provide regulatory guidance and strategic advice to project teams throughout the drug development lifecycle.
- Monitor and interpret regulatory intelligence, assessing its impact on company products and strategies.
- Ensure that company processes and products comply with current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).
- Manage post-approval regulatory commitments, including annual reports and safety updates.
- Develop and maintain regulatory submission timelines and strategies.
- Review and approve promotional materials and labeling to ensure regulatory compliance.
- Support regulatory inspections and audits.
- Contribute to the development and implementation of regulatory SOPs and policies.
- Conduct regulatory training for relevant personnel.
- Assess the regulatory impact of manufacturing process changes and formulation modifications.
Qualifications and Experience:
- Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field. A PhD is advantageous.
- Minimum of 5-7 years of progressive experience in pharmaceutical regulatory affairs.
- In-depth knowledge of regulatory requirements and guidelines in key markets (e.g., UK, EU, US).
- Proven experience in preparing and submitting various types of regulatory dossiers (e.g., CTD format).
- Excellent understanding of drug development processes, manufacturing, and quality assurance.
- Strong analytical, problem-solving, and critical thinking skills.
- Exceptional written and verbal communication skills, with meticulous attention to detail.
- Proficiency in regulatory information management systems and MS Office Suite.
- Ability to manage multiple projects simultaneously and meet strict deadlines.
- Team player with strong interpersonal skills, capable of collaborating effectively across departments.
This is a vital role within our client's organization, offering the chance to contribute significantly to bringing life-saving medicines to patients. If you possess the required expertise and are looking for a challenging and rewarding career, we encourage you to apply.
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2
Senior Pharmaceutical Regulatory Affairs Manager
RG1 1DL Reading, South East
£70000 Annually
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Our client, a prominent pharmaceutical company dedicated to developing life-changing medicines, is seeking an experienced Senior Pharmaceutical Regulatory Affairs Manager. This hybrid role, based in Reading, Berkshire, UK , involves strategic leadership in navigating the complex landscape of pharmaceutical regulations. You will be responsible for overseeing the preparation, submission, and maintenance of regulatory filings for new drug applications and existing products across key global markets. This includes ensuring compliance with all relevant regulatory guidelines and standards, liaising with health authorities, and providing expert regulatory guidance to internal R&D, clinical, and commercial teams. The ideal candidate will possess a deep understanding of regulatory frameworks and a proven ability to manage regulatory strategies from pre-clinical stages through to post-market surveillance.
Key Responsibilities:
Key Responsibilities:
- Develop and implement regulatory strategies for product development and lifecycle management.
- Prepare and submit high-quality regulatory dossiers (e.g., CTD, IND, NDA) to health authorities worldwide.
- Serve as the primary point of contact with regulatory agencies, managing communications and responding to queries.
- Ensure ongoing compliance with all applicable pharmaceutical regulations and guidelines.
- Provide regulatory input and guidance to R&D, clinical development, manufacturing, and marketing teams.
- Review promotional materials and labeling for regulatory compliance.
- Conduct regulatory intelligence activities to stay abreast of evolving regulations and provide strategic advice.
- Manage regulatory aspects of product variations, renewals, and post-approval commitments.
- Oversee and mentor junior regulatory affairs professionals.
- Participate in regulatory inspections and audits.
- Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field; advanced degree (MSc, PhD) is preferred.
- Minimum of 6 years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of global pharmaceutical regulatory requirements and guidelines (e.g., FDA, EMA, ICH).
- Proven experience in preparing and submitting regulatory filings for various drug products.
- Strong understanding of drug development processes, including pre-clinical, clinical, and manufacturing.
- Excellent written and verbal communication skills, with the ability to articulate complex regulatory issues clearly and concisely.
- Strong analytical, problem-solving, and strategic thinking abilities.
- Experience interacting directly with regulatory health authorities.
- Ability to manage multiple projects and prioritize effectively in a fast-paced environment.
- Leadership experience and strong team collaboration skills.
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3
Senior Pharmaceutical Regulatory Affairs Manager
SW1A 0AA London, London
£75000 Annually
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Our client is seeking an accomplished Senior Pharmaceutical Regulatory Affairs Manager to lead their regulatory strategy. This is a vital, fully remote position, allowing you to contribute significantly to their global operations from anywhere within the UK. As a Senior Regulatory Affairs Manager, you will be instrumental in guiding the company through the complex landscape of pharmaceutical regulations, ensuring that products meet all necessary requirements for market approval and continued compliance. Your responsibilities will encompass the preparation and submission of regulatory dossiers (e.g., CTD, NDA, MAA) to health authorities worldwide, including the EMA, FDA, and MHRA. You will provide strategic regulatory guidance to internal teams, including R&D, clinical development, and commercial operations, to ensure that regulatory considerations are integrated into product development lifecycles. This role requires a deep understanding of global regulatory submission processes, post-approval changes, and lifecycle management. You will stay abreast of evolving regulatory guidelines and assess their impact on the company's products and pipeline. The ideal candidate will possess excellent analytical, communication, and negotiation skills, with a proven ability to manage complex projects and build strong relationships with regulatory agencies. You will lead and mentor a team of regulatory affairs professionals, fostering a culture of excellence and compliance. Experience in a specific therapeutic area relevant to our client's portfolio would be advantageous. This position demands a proactive, strategic thinker who can navigate regulatory challenges effectively and contribute to the successful global commercialization of pharmaceutical products. It's an outstanding opportunity to exert significant influence on regulatory direction and support patient access to innovative medicines.
Key Responsibilities:
Key Responsibilities:
- Develop and execute global regulatory affairs strategies for pharmaceutical products.
- Prepare and submit regulatory dossiers (e.g., INDs, NDAs, MAAs) to health authorities.
- Provide strategic regulatory guidance to cross-functional teams throughout product development.
- Manage post-approval regulatory activities, including variations and lifecycle management.
- Liaise with regulatory agencies and respond to queries during the review process.
- Monitor and interpret evolving regulatory requirements and assess their impact.
- Lead and mentor a team of regulatory affairs professionals.
- Ensure compliance with all applicable regulations and guidelines.
- Bachelor's or Master's degree in a relevant scientific discipline (e.g., Pharmacy, Life Sciences).
- Minimum of 8 years of experience in pharmaceutical regulatory affairs.
- Proven track record of successful regulatory submissions and approvals.
- In-depth knowledge of global regulatory requirements (FDA, EMA, MHRA).
- Experience with eCTD formatting and submission processes.
- Strong understanding of drug development and manufacturing processes.
- Excellent leadership, communication, and negotiation skills.
- Ability to manage multiple projects and prioritize effectively.
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4
Senior Pharmaceutical Regulatory Affairs Specialist
M1 1AA Manchester, North West
£65000 Annually
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Our client, a prominent player in the pharmaceutical industry, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their dynamic team in **Manchester, Greater Manchester, UK**. This hybrid role involves navigating complex regulatory landscapes to ensure compliance and facilitate the successful approval and lifecycle management of pharmaceutical products.
The Senior Regulatory Affairs Specialist will be responsible for preparing, submitting, and maintaining regulatory filings with health authorities worldwide (e.g., MHRA, FDA, EMA). You will provide strategic regulatory guidance on product development, clinical trials, manufacturing processes, and marketing strategies. This role requires a meticulous approach, a deep understanding of global pharmaceutical regulations, and strong communication skills to liaise effectively with both internal teams and external regulatory bodies. You will play a vital role in bringing life-saving medicines to market.
Key responsibilities include:
Essential qualifications and experience:
This is an exceptional opportunity for a seasoned regulatory professional to contribute to a leading pharmaceutical company and impact global health. If you possess the required expertise and are looking for a challenging role with growth potential, we encourage you to apply.
The Senior Regulatory Affairs Specialist will be responsible for preparing, submitting, and maintaining regulatory filings with health authorities worldwide (e.g., MHRA, FDA, EMA). You will provide strategic regulatory guidance on product development, clinical trials, manufacturing processes, and marketing strategies. This role requires a meticulous approach, a deep understanding of global pharmaceutical regulations, and strong communication skills to liaise effectively with both internal teams and external regulatory bodies. You will play a vital role in bringing life-saving medicines to market.
Key responsibilities include:
- Developing and executing regulatory strategies for new drug applications (NDAs) and variations.
- Preparing and compiling high-quality regulatory submission dossiers (e.g., CTD format).
- Interacting with regulatory agencies, responding to queries, and managing the review process.
- Ensuring compliance with relevant regulations and guidelines throughout the product lifecycle.
- Providing regulatory input on product labeling, advertising, and promotional materials.
- Conducting regulatory intelligence activities to stay updated on changing requirements and advise the business accordingly.
- Collaborating with R&D, clinical, manufacturing, and marketing departments to ensure regulatory requirements are met.
- Assessing the regulatory impact of manufacturing changes and post-approval commitments.
- Mentoring junior regulatory affairs professionals.
Essential qualifications and experience:
- A Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
- A minimum of 5-7 years of experience in pharmaceutical regulatory affairs.
- Proven experience in preparing and submitting regulatory dossiers for major health authorities.
- In-depth knowledge of ICH guidelines and regional regulatory requirements.
- Excellent written and verbal communication skills, with strong attention to detail.
- Strong analytical and problem-solving abilities.
- Ability to manage multiple projects simultaneously and meet strict deadlines.
- Experience with regulatory information management systems is a plus.
- A proactive and collaborative approach to working within cross-functional teams.
This is an exceptional opportunity for a seasoned regulatory professional to contribute to a leading pharmaceutical company and impact global health. If you possess the required expertise and are looking for a challenging role with growth potential, we encourage you to apply.
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5
Senior Pharmaceutical Regulatory Affairs Specialist
NG1 3DT Nottingham, East Midlands
£60000 Annually
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Our client, a leading pharmaceutical company, is seeking an experienced Senior Pharmaceutical Regulatory Affairs Specialist to join their dedicated team in **Nottingham, Nottinghamshire, UK**. This hybrid role offers the opportunity to contribute to the successful navigation of complex regulatory landscapes, balancing essential in-office collaboration with the flexibility of remote work. You will be responsible for managing regulatory submissions, ensuring compliance with global health authority requirements, and providing strategic regulatory guidance throughout the product lifecycle. This includes working with regulatory agencies such as the MHRA, EMA, and FDA. The ideal candidate will possess a deep understanding of pharmaceutical regulations, excellent analytical and communication skills, and a meticulous approach to documentation and compliance.
Key Responsibilities:
Qualifications:
Key Responsibilities:
- Prepare, review, and submit regulatory dossiers for new drug applications (NDAs) and variations to existing marketing authorizations.
- Ensure compliance with current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), and Good Pharmacovigilance Practices (GVP).
- Interpret and apply global regulatory guidelines and advise project teams accordingly.
- Liaise with regulatory agencies, respond to queries, and manage post-approval activities.
- Develop and implement regulatory strategies for product development and lifecycle management.
- Conduct regulatory intelligence activities to stay abreast of evolving requirements.
- Review and approve labeling, advertising, and promotional materials for regulatory compliance.
- Manage the regulatory aspects of product recalls and quality issues.
- Collaborate with R&D, manufacturing, clinical, and marketing departments.
- Train and mentor junior regulatory affairs professionals.
Qualifications:
- Degree in Pharmacy, Life Sciences, Chemistry, or a related field; advanced degree preferred.
- 5+ years of experience in pharmaceutical regulatory affairs.
- In-depth knowledge of regulatory requirements in key markets (e.g., UK, EU, US).
- Proven experience in preparing and submitting MAAs, CTAs, and variations.
- Excellent understanding of the drug development process and lifecycle management.
- Strong analytical, problem-solving, and project management skills.
- Exceptional written and verbal communication skills.
- Experience with regulatory information management systems.
- Ability to work effectively in a hybrid work environment and manage multiple projects simultaneously.
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Remote Pharmaceutical Regulatory Affairs Manager
WV1 1AB Wolverhampton, West Midlands
£70000 Annually
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Our client, a rapidly growing biopharmaceutical company focused on developing innovative therapies, is seeking an experienced and strategic Remote Pharmaceutical Regulatory Affairs Manager to join their expanding global team. This critical role will be responsible for developing and executing regulatory strategies for new and existing pharmaceutical products, ensuring compliance with international regulatory requirements and guidelines. You will oversee the preparation and submission of regulatory dossiers (e.g., INDs, NDAs, MAAs), liaise with regulatory health authorities (such as the FDA, EMA, MHRA), and provide regulatory guidance throughout the product development lifecycle. The ideal candidate will have a deep understanding of the pharmaceutical drug development process, global regulatory landscapes, and a proven track record of successful regulatory submissions and approvals. Experience with biologics or advanced therapy medicinal products (ATMPs) is highly advantageous.
This position is fully remote, allowing you to contribute to groundbreaking pharmaceutical advancements from anywhere in the UK. You will collaborate closely with cross-functional teams, including R&D, clinical operations, manufacturing, and quality assurance, to ensure regulatory requirements are integrated into all aspects of product development and commercialization. Responsibilities include staying abreast of evolving regulatory intelligence, assessing the regulatory impact of changes, and managing regulatory documentation effectively. Strong project management, excellent communication, and exceptional analytical and problem-solving skills are essential for success in this role. We are looking for a motivated and proactive regulatory professional who can navigate complex regulatory challenges and contribute significantly to bringing vital medicines to patients worldwide. You will be a key contributor to our client's mission to improve global health outcomes.
Key responsibilities:
Qualifications:
This position is fully remote, allowing you to contribute to groundbreaking pharmaceutical advancements from anywhere in the UK. You will collaborate closely with cross-functional teams, including R&D, clinical operations, manufacturing, and quality assurance, to ensure regulatory requirements are integrated into all aspects of product development and commercialization. Responsibilities include staying abreast of evolving regulatory intelligence, assessing the regulatory impact of changes, and managing regulatory documentation effectively. Strong project management, excellent communication, and exceptional analytical and problem-solving skills are essential for success in this role. We are looking for a motivated and proactive regulatory professional who can navigate complex regulatory challenges and contribute significantly to bringing vital medicines to patients worldwide. You will be a key contributor to our client's mission to improve global health outcomes.
Key responsibilities:
- Develop and implement global regulatory strategies for pharmaceutical products.
- Prepare and submit regulatory dossiers (IND, NDA, BLAs, MAAs, etc.) to health authorities.
- Serve as the primary regulatory contact with health authorities worldwide.
- Provide regulatory guidance and expertise to project teams throughout the product lifecycle.
- Ensure compliance with all applicable local, national, and international regulations and guidelines.
- Manage post-approval regulatory activities, including supplements and variations.
- Conduct regulatory intelligence gathering and assess the impact of new regulations.
- Review and approve promotional materials and product labelling for regulatory compliance.
- Contribute to the development of regulatory policies and procedures.
- Mentor and guide junior regulatory affairs professionals.
Qualifications:
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related scientific discipline. Advanced degree (e.g., PhD, PharmD) is preferred.
- Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
- Demonstrated success in preparing and leading regulatory submissions for various product types.
- In-depth knowledge of global regulatory requirements (FDA, EMA, MHRA, etc.) and ICH guidelines.
- Experience with regulatory strategy development and implementation.
- Strong understanding of drug development processes, CMC, and clinical trial regulations.
- Excellent written and verbal communication skills, with strong attention to detail.
- Proficiency in regulatory information management systems.
- Ability to work independently and collaboratively in a fully remote setting.
- Project management skills and the ability to manage multiple complex projects simultaneously.
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7
Remote Pharmaceutical Regulatory Affairs Specialist
BN1 1AB East Sussex, South East
£55000 Annually
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Our client is seeking a highly skilled and meticulous Pharmaceutical Regulatory Affairs Specialist to join their established team on a fully remote basis. This pivotal role ensures that our client's pharmaceutical products comply with all relevant national and international regulations throughout their lifecycle. You will be responsible for preparing, reviewing, and submitting regulatory documentation to health authorities, contributing to the successful development and commercialization of innovative medicines.
This remote position requires exceptional organizational skills, a proactive approach to problem-solving, and a thorough understanding of pharmaceutical regulations, guidelines, and submission processes. You will collaborate closely with cross-functional teams, including R&D, Quality Assurance, and Marketing, to ensure timely and accurate regulatory submissions and approvals. The ability to work independently, manage multiple projects, and maintain clear communication channels in a virtual environment is paramount.
Key Responsibilities:
This remote position requires exceptional organizational skills, a proactive approach to problem-solving, and a thorough understanding of pharmaceutical regulations, guidelines, and submission processes. You will collaborate closely with cross-functional teams, including R&D, Quality Assurance, and Marketing, to ensure timely and accurate regulatory submissions and approvals. The ability to work independently, manage multiple projects, and maintain clear communication channels in a virtual environment is paramount.
Key Responsibilities:
- Prepare, review, and maintain regulatory submissions (e.g., CTD, IND, NDA, MAA) for new drug applications and variations.
- Interpret and apply relevant pharmaceutical regulations, guidelines, and standards from authorities such as the MHRA, EMA, and FDA.
- Liaise with health authorities for pre-submission meetings, deficiency letters, and responses.
- Develop and implement regulatory strategies for product development and lifecycle management.
- Ensure compliance of product labeling, advertising, and promotional materials with regulatory requirements.
- Monitor regulatory intelligence and advise on changes that may impact the company's products or operations.
- Provide regulatory guidance and support to internal teams throughout the drug development process.
- Manage post-approval regulatory activities, including annual reports and lifecycle management submissions.
- Conduct internal audits and training on regulatory compliance.
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8
Senior Pharmaceutical Regulatory Affairs Manager
BD1 1AA Bradford, Yorkshire and the Humber
£70000 Annually
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Job Description
Our client, a leading global pharmaceutical company, is seeking a highly experienced Senior Pharmaceutical Regulatory Affairs Manager to join their team in Bradford, West Yorkshire, UK . This pivotal role will be responsible for ensuring compliance with all national and international regulatory requirements throughout the product lifecycle, from development to post-market surveillance. You will play a critical role in preparing and submitting regulatory dossiers, engaging with health authorities, and providing strategic regulatory guidance to cross-functional teams. This hybrid position offers the opportunity to contribute to life-saving medications while balancing in-office collaboration and remote flexibility.
Key Responsibilities:
Key Responsibilities:
- Developing and executing regulatory strategies for the development, registration, and lifecycle management of pharmaceutical products.
- Preparing, reviewing, and submitting high-quality regulatory dossiers (e.g., CTD, IND, NDA, MAA) to global health authorities.
- Interpreting and advising on current and emerging regulatory guidelines and legislation.
- Managing regulatory submissions and ensuring timely responses to health authority queries.
- Serving as a key liaison between the company and regulatory agencies (e.g., MHRA, EMA, FDA).
- Providing regulatory input and support to R&D, clinical operations, manufacturing, and marketing teams.
- Conducting regulatory due diligence for potential acquisitions and partnerships.
- Developing and implementing internal processes and training programs to ensure regulatory compliance.
- Managing post-approval regulatory activities, including variations, renewals, and pharmacovigilance reporting.
- Contributing to the development of labeling and promotional materials to ensure regulatory compliance.
- Leading and mentoring junior regulatory affairs professionals.
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