27 Government Affairs Consultants jobs in London
Regulatory Affairs Manager
Posted 1 day ago
Job Viewed
Job Description
Walker Cole are recruiting for a Regulatory Affairs Manager position for an early stage ATMP pharmaceutical business. This is an exciting opportunity for a junior professional to grow and develop within the ATMP space from a range of skills and experience within the team.
A Regulatory Manager will bring:
- Regulatory CMC experience at early-stage development in ATMP and/or biological products
- A drive and willingness to learn and grow within this space.
- Ability to work well within a team, cross functionally and independently
As a Regulatory Manager you will:
- Work within an expert team on Regulatory CMC
- Support in CMC gap analysis, write guidance document and IMAPs
- IMPD, IND submissions and pre-clinical activities.
Early-Stage // Development // Pre-clinical // Regulatory CMC // Regulatory Affairs // Biologics // ATMP // Advanced Therapy //
Regulatory Affairs Officer
Posted 1 day ago
Job Viewed
Job Description
Overall Job Purpose:
The Regulatory Affairs (RA) Officer is primarily responsible for ensuring the appropriate licensing, marketing and legal compliance of Sun Pharma’s pharmaceutical and medical products in order to control the safety and efficacy of these products. The RA Officer combines scientific, legal and business knowledge to ensure Sun Pharma’s products meet the required legislation. He/she is responsible for the approval and registration of Sun Pharma’s products in UK market.
Responsibilities:
- Is responsible for liaising with internal and external partners to receive the necessary documents in a timely manner, e.g. internally with R&D, RA and art work departments, externally with translations services and consultants for e.g. Package Leaflet User test reports.
- Is responsible for the preparation of SmPC, labelling and PILs texts according to the Quality Review of Documents (QRD) format.
- Is responsible for text verification of the product information documents.
- Is responsible for proof reading of art work of packaging materials.
- Ensure dossier technical content is optimal and aligned with UK Regulatory data requirements for new UK Marketing Authorisation Applications
- Maintains the life cycle management of the dossiers or the approved marketing authorizations as required by submitting variations/notifications/PSURs and renewals.
- Liaises with regulatory colleagues in the different country offices, corporate groups and competent authorities (MHRA) and third parties on regulatory issues.
- Works closely together with internal customers such as Research & Development, Artwork, Pharmacovigilance, Quality Assurance, Logistics, Finance, Business Development, Sales.
- Maintains RA archives (electronically).
- Keeps the Regulatory Information correct and accessible for other stakeholders.
- Being able to work with the required IT standards, like eCTD, XEVMPD
- Being able to work with the corporate IT systems like AMS, Trackwise, eDMS, eLMS, OneHR
- Determines and writes standard operating procedures.
Qualifications:
- Bachelor or Master Degree (preferably in Life Sciences, Languages or Law)
- 2-5 years of experience in pharma
- Rounded knowledge of the UK and EU Regulatory Framework (directives, regulations, guidelines)
- Some understanding of the drug development process
- Able to comply with company standard operating procedures
- Good verbal and written communication skills in English
- Good IT skills including familiarity with Microsoft Office packages and specific packages/portals such as eCTD software, XEVMPD software, TVT, CESP, EMA gateway, MHRA and CBG portal.
- Excellent attention to detail
- Good time management skills
- Good organization and project management skills
- Good interpersonal and team working skills
- Presentation skills and experience of delivering training
Regulatory Affairs Specialist
Posted 3 days ago
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Job Description
Join a leading innovator in the chemical sector, driving compliance and sustainability across global markets. We’re seeking a detail-oriented Regulatory Affairs Specialist with a strong foundation in chemical regulations to ensure our products meet all legal and safety standards.
The Role
As a Regulatory Affairs Specialist , you will play a pivotal role in managing product registrations, preparing regulatory documentation, and maintaining compliance with national and international chemical legislation (REACH, CLP, SDS, etc.). You’ll collaborate with R&D, Quality, and Commercial teams to support new product introductions and ensure continuous regulatory alignment.
Key Responsibilities
- Prepare, review, and submit product registration dossiers and notifications.
- Maintain up-to-date knowledge of chemical regulations and compliance requirements.
- Support Safety Data Sheet (SDS) authoring and classification activities.
- Liaise with regulatory authorities and third-party consultants.
- Contribute to internal audits and compliance projects.
- Provide regulatory guidance for product development and market access.
The requirements
- Bachelor’s degree (or higher) in Chemistry, Toxicology, Environmental Science, or a related field.
- Minimum 2 years’ experience in regulatory affairs within the chemical, pharmaceutical, nutraceutical and/or food industries .
- Working knowledge of REACH, CLP, and GHS regulations.
- Strong analytical, organizational, and communication skills.
- Ability to manage multiple projects and deadlines effectively.
Regulatory Affairs Manager
Posted today
Job Viewed
Job Description
Walker Cole are recruiting for a Regulatory Affairs Manager position for an early stage ATMP pharmaceutical business. This is an exciting opportunity for a junior professional to grow and develop within the ATMP space from a range of skills and experience within the team.
A Regulatory Manager will bring:
- Regulatory CMC experience at early-stage development in ATMP and/or biological products
- A drive and willingness to learn and grow within this space.
- Ability to work well within a team, cross functionally and independently
As a Regulatory Manager you will:
- Work within an expert team on Regulatory CMC
- Support in CMC gap analysis, write guidance document and IMAPs
- IMPD, IND submissions and pre-clinical activities.
Early-Stage // Development // Pre-clinical // Regulatory CMC // Regulatory Affairs // Biologics // ATMP // Advanced Therapy //
Regulatory Affairs Officer
Posted today
Job Viewed
Job Description
Overall Job Purpose:
The Regulatory Affairs (RA) Officer is primarily responsible for ensuring the appropriate licensing, marketing and legal compliance of Sun Pharma’s pharmaceutical and medical products in order to control the safety and efficacy of these products. The RA Officer combines scientific, legal and business knowledge to ensure Sun Pharma’s products meet the required legislation. He/she is responsible for the approval and registration of Sun Pharma’s products in UK market.
Responsibilities:
- Is responsible for liaising with internal and external partners to receive the necessary documents in a timely manner, e.g. internally with R&D, RA and art work departments, externally with translations services and consultants for e.g. Package Leaflet User test reports.
- Is responsible for the preparation of SmPC, labelling and PILs texts according to the Quality Review of Documents (QRD) format.
- Is responsible for text verification of the product information documents.
- Is responsible for proof reading of art work of packaging materials.
- Ensure dossier technical content is optimal and aligned with UK Regulatory data requirements for new UK Marketing Authorisation Applications
- Maintains the life cycle management of the dossiers or the approved marketing authorizations as required by submitting variations/notifications/PSURs and renewals.
- Liaises with regulatory colleagues in the different country offices, corporate groups and competent authorities (MHRA) and third parties on regulatory issues.
- Works closely together with internal customers such as Research & Development, Artwork, Pharmacovigilance, Quality Assurance, Logistics, Finance, Business Development, Sales.
- Maintains RA archives (electronically).
- Keeps the Regulatory Information correct and accessible for other stakeholders.
- Being able to work with the required IT standards, like eCTD, XEVMPD
- Being able to work with the corporate IT systems like AMS, Trackwise, eDMS, eLMS, OneHR
- Determines and writes standard operating procedures.
Qualifications:
- Bachelor or Master Degree (preferably in Life Sciences, Languages or Law)
- 2-5 years of experience in pharma
- Rounded knowledge of the UK and EU Regulatory Framework (directives, regulations, guidelines)
- Some understanding of the drug development process
- Able to comply with company standard operating procedures
- Good verbal and written communication skills in English
- Good IT skills including familiarity with Microsoft Office packages and specific packages/portals such as eCTD software, XEVMPD software, TVT, CESP, EMA gateway, MHRA and CBG portal.
- Excellent attention to detail
- Good time management skills
- Good organization and project management skills
- Good interpersonal and team working skills
- Presentation skills and experience of delivering training
Associate Director Regulatory Affairs
Posted today
Job Viewed
Job Description
Job title: Associate Director, Regulatory Affairs
A Pharmaceutical business in London is looking for an Associate Director, Regulatory Affairs to join their team. In this role you will hold either a EU Regulatory Lead role or Global Regulatory Lead role depending on the portfolio of products assigned.
Responsibilities:
- Working together with multi-functional / geographical teams and other internal stakeholders to ensure that projects meet all key objectives and are delivered on time.
- Develop Regulatory Strategies for any new submissions as well as identifying risks.
- Contribute to the preparation of briefing packages for Scientific Advice and orphan drug designations.
- Participate during the interactions with Health Authorities.
Requirements:
- Substantial experience within Regulatory affairs and pharmaceutical industry.
- Extensive experience in the submission of new products.
- Experience working with new MA's.
- Experience interacting with EU/UK regulatory authorities.
Salary and benefits:
A highly competitive salary and wider benefits scheme is on offer.
To apply for this position or hear further details then please contact Freddie Hill via
Head of Regulatory Affairs
Posted 1 day ago
Job Viewed
Job Description
Head of Regulatory Affairs
An outstanding opportunity has arisen within a leading, innovation-driven pharmaceutical company dedicated to delivering value-based, patient-centric healthcare solutions. As Head of Regulatory Affairs for the UK and Ireland, you will play a pivotal role on the Leadership Team, shaping and executing bold, forward-looking regulatory strategies across the entire pharmaceutical portfolio.
In this influential position, you will lead a highly skilled team of 12 professionals, driving innovative and sustainable regulatory solutions that enable timely and optimal product access. Working across early development, pre-launch, and lifecycle management, you will oversee a significant number of high-profile launches planned over the next three years. This is a rare opportunity for a strategic and visionary leader to shape the future of access in the UK and Ireland, ensuring that regulatory strategies not only enable market success but also deliver lasting value for patients.
Your approach will align closely with the company’s long-term objectives, therapeutic area priorities, and overarching mission to advance patient care, ultimately driving both regulatory excellence and sustainable business growth in a dynamic and evolving healthcare landscape.
Job Requirements:
- A degree in life sciences, health economics, epidemiology, or postgraduate qualification (e.g., MSc, PhD) in Health Economics, Market Access, or Public Health
- Long-term experience in, and demonstrated understanding of the pharmaceutical/biotech industry, managing prescription and innovative medicine
- Extensive experience focused on Market Access, Pricing, Contracting, Sales, Commerical and Marketing
- A comprehensive and in-depth understanding of the UK and Ireland healthcare systems, with expertise in navigating the complexities of Health Technology Assessment (HTA) processes, payer bodies, and reimbursement systems, including familiarity with key players, policy frameworks
- Proven track record of leading HTA submissions and executing competitive pricing models and commercial contracts with the NHS
- Comfortable building and adapting strategies across pre-launch, launch, and post-launch access stages, with proven experience in both pre- and post-launch phases
- Experience in Leadership and Team Management: Experience in managing direct reports (not just cross-functional leadership)
Education:
- Master’s degree or equivalent in Pharmacy or Life Sciences.
- Advanced qualifications such as a PhD, MD, PharmD, Specialised Pharmacist, or Master’s in Drug Regulatory Affairs are highly valued
- Vast experience in the life sciences and/or pharmaceutical industry, focused to Regulatory Affairs, with strong national experience for UK and Ireland
- Comprehensive understanding of the global drug development process, regulatory frameworks, and procedures covering product development, submission, and lifecycle management
- Proven experience in direct interactions with Health Authorities, supporting Clinical Trial Applications (CTAs), Marketing Authorisation Applications (MAAs), variations, renewals, and related submissions
- Several years of experience in leading international and cross-functional project teams, as well as direct leadership of Regulatory Affairs team leads and managers
- In-depth knowledge of local regulatory requirements, including the ability to interpret and apply complex legislation effectively
If you are an inspiring leader with a passion for innovation, we encourage you to apply early.
If you have the skills and experience for this opportunity and the ambition to take on this position, please contact Vicki for further details or email your CV today.
- By email:
- By phone: +44 (0) or +44 (0)
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Regulatory Affairs Manager - CMC
Posted 1 day ago
Job Viewed
Job Description
Hobson Prior is seeking a Regulatory Affairs Manager - CMC to join a dynamic team in the biotech industry. In this role, you will focus on regulatory strategies and submissions related to Chemistry, Manufacturing, and Controls (CMC). This is an exciting opportunity to contribute to pre-clinical and early-phase projects in a rapidly evolving therapeutic area.
Please note that to be considered for this role you must have the right to work in this location.
Responsibilities:
- Lead the preparation of regulatory documents, including clinical trial applications (CTA), investigational new drug (IND) submissions, and genetically modified organism (GMO) applications.
- Collaborate with various teams to ensure manufacturing and analytical processes meet regulatory standards.
- Provide strategic input on regulatory pathways for complex biologics or biotech products.
Key Skills and Requirements:
- Strong understanding of regulatory processes, particularly in the EU and US.
- Experience with biologics, with a preference for candidates familiar with cell and gene therapy.
- Ability to work effectively across teams and adapt to a fast-paced environment.
For more information, please contact Syem Mannan .
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data -
Sr Mgr Regulatory Affairs
Posted 6 days ago
Job Viewed
Job Description
Join us in shaping the future of oncology treatments and making a meaningful impact on patients' lives.
**A Typical Day:**
As a Regulatory Affairs Manager, your day might include:
+ Developing regulatory strategies for oncology programs by researching guidelines, EU precedents, and emerging trends.
+ Managing CTA submissions via CTIS for multiple EU member states, ensuring compliance with EU requirements.
+ Organizing, preparing, and reviewing CTA amendments, annual reports, and other regulatory documents.
+ Performing critical analyses of clinical and preclinical data to develop interpretations and conclusions.
+ Leading EU Scientific Advice requests and coordinating EMA and EU national agency meetings.
+ Monitoring newly published EU Commission and EMA guidelines to ensure compliance and provide training for scientific staff.
+ Representing Regeneron Regulatory Affairs in engagements with EMA scientific committees, EU national agencies, and industry associations.
**This Role May Be For You If:**
You are someone who:
+ Thrives in a collaborative environment and enjoys working with multidisciplinary teams.
+ Has a proven ability to navigate EU regulatory frameworks and requirements.
+ Is detail-oriented and skilled in analyzing clinical and preclinical data.
+ Has experience leading regulatory agency meetings and negotiating effectively with stakeholders.
+ Is passionate about contributing to oncology drug development programs.
+ Values continuous learning and stays updated on emerging regulatory trends.
+ Has excellent written and verbal communication skills.
**To Be Considered:**
We're looking for candidates with:
+ An advanced degree in a scientific discipline.
+ At least 4 years of regulatory experience, with a focus on clinical development.
+ Proven experience supporting EU Clinical Trial Applications through approval and study start-up.
+ Familiarity with EMA processes such as scientific advice, orphan designation, and PIPs.
+ Experience in oncology regulatory strategy is an advantage.
+ A strong ability to negotiate and express clear positions to stakeholders at all levels.
+ Preferred qualifications include experience with marketing authorization applications or life-cycle management of approved products in the centralized procedure.
**Why Join Us?**
At Regeneron, we believe in fostering innovation, collaboration, and growth. You'll have the opportunity to work with a passionate team dedicated to advancing science and improving patient outcomes. Together, we'll make a difference.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Associate Director Regulatory Affairs
Posted today
Job Viewed
Job Description
Job title: Associate Director, Regulatory Affairs
A Pharmaceutical business in London is looking for an Associate Director, Regulatory Affairs to join their team. In this role you will hold either a EU Regulatory Lead role or Global Regulatory Lead role depending on the portfolio of products assigned.
Responsibilities:
- Working together with multi-functional / geographical teams and other internal stakeholders to ensure that projects meet all key objectives and are delivered on time.
- Develop Regulatory Strategies for any new submissions as well as identifying risks.
- Contribute to the preparation of briefing packages for Scientific Advice and orphan drug designations.
- Participate during the interactions with Health Authorities.
Requirements:
- Substantial experience within Regulatory affairs and pharmaceutical industry.
- Extensive experience in the submission of new products.
- Experience working with new MA's.
- Experience interacting with EU/UK regulatory authorities.
Salary and benefits:
A highly competitive salary and wider benefits scheme is on offer.
To apply for this position or hear further details then please contact Freddie Hill via -partners.co.uk