56 Regulatory Affairs Positions jobs in London

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 //

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 -

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 - -policy.

Our client, a globally recognised pharmaceutical organisation dedicated to enhancing global health outcomes, is seeking a strategic and experienced Remote Pharmaceutical Regulatory Affairs Manager. This is a critical, fully remote position where you will drive the regulatory strategy and execution for our innovative product portfolio. You will be responsible for ensuring compliance with all relevant national and international pharmaceutical regulations, including those set by the MHRA, EMA, and FDA. The ideal candidate will possess extensive experience in pharmaceutical regulatory affairs, with a deep understanding of drug development, manufacturing, and lifecycle management. Your responsibilities will include preparing and submitting regulatory dossiers (e.g., CTAs, MAAs, NDAs), responding to health authority queries, and managing post-approval regulatory activities. You will stay abreast of evolving regulatory landscapes, providing expert guidance to internal teams on regulatory requirements and strategies. Excellent analytical, communication, and project management skills are paramount. You will collaborate closely with R&D, clinical operations, quality assurance, and commercial teams to ensure seamless integration of regulatory considerations into project timelines and strategies. This role demands a proactive approach to regulatory compliance and a strong ability to navigate complex regulatory challenges. Experience in strategic regulatory planning, regulatory intelligence, and health authority interactions is essential. You will be a key advisor on regulatory policy and compliance, ensuring our products reach patients safely and effectively. This remote role offers the flexibility to work from your home office, contributing significantly to our company's mission, while being an integral part of our client's operations, which have a significant presence in **London, England, UK**, and globally.

We are seeking an experienced Regulatory Affairs Manager to join on a 12-month fixed-term contract , supporting compliance and nutrition across multiple European markets. This is a senior role with broad cross-functional exposure, ideal for someone with strong regulatory expertise who thrives in a fast-paced international environment.

Key Responsibilities

• Act as a subject matter expert on European food regulations, labelling, and claims.
• Provide expert guidance on regulatory matters for existing, new, and reformulated products.
• Lead the regulatory review and approval of consumer labels in English and French, with potential oversight of additional European markets.
• Manage and resolve complex regulatory incidents , engaging with internal teams and external authorities.
• Monitor and interpret emerging legislation , shaping compliance strategies and contributing to industry discussions.
• Support cross-functional projects, including product development, reformulations, and marketing communications.
• Drive improvements in regulatory processes and systems, including the rollout of new labelling software.
• Manage and develop contractors, ensuring delivery of compliance-related activities.

About You

• Degree in Life Sciences required; Master’s preferred.
• 8–10+ years’ experience in regulatory affairs/nutrition with a strong focus on European markets.
• 5+ years’ experience leading teams preferred.
• Deep knowledge of European food regulations and labelling requirements.
• Fluent in English and French (additional European languages an advantage).
• Excellent communication and influencing skills, with proven ability to manage senior stakeholders.
• Skilled in Microsoft Office, Adobe, SAP-PLM, and product lifecycle management systems .

What’s on Offer

• A 12-month fixed-term contract with significant responsibility and visibility.
• The opportunity to work across multiple markets and regulatory environments.
• A chance to shape compliance processes and contribute to industry discussions at European level.

Job Description

We are seeking an experienced Regulatory Affairs Manager to join on a 12-month fixed-term contract , supporting compliance and nutrition across multiple European markets. This is a senior role with broad cross-functional exposure, ideal for someone with strong regulatory expertise who thrives in a fast-paced international environment.

Key Responsibilities

• Act as a subject matter expert on European food regulations, labelling, and claims.
• Provide expert guidance on regulatory matters for existing, new, and reformulated products.
• Lead the regulatory review and approval of consumer labels in English and French, with potential oversight of additional European markets.
• Manage and resolve complex regulatory incidents , engaging with internal teams and external authorities.
• Monitor and interpret emerging legislation , shaping compliance strategies and contributing to industry discussions.
• Support cross-functional projects, including product development, reformulations, and marketing communications.
• Drive improvements in regulatory processes and systems, including the rollout of new labelling software.
• Manage and develop contractors, ensuring delivery of compliance-related activities.

About You

• Degree in Life Sciences required; Master’s preferred.
• 8–10+ years’ experience in regulatory affairs/nutrition with a strong focus on European markets.
• 5+ years’ experience leading teams preferred.
• Deep knowledge of European food regulations and labelling requirements.
• Fluent in English and French (additional European languages an advantage).
• Excellent communication and influencing skills, with proven ability to manage senior stakeholders.
• Skilled in Microsoft Office, Adobe, SAP-PLM, and product lifecycle management systems .

What’s on Offer

• A 12-month fixed-term contract with significant responsibility and visibility.
• The opportunity to work across multiple markets and regulatory environments.
• A chance to shape compliance processes and contribute to industry discussions at European level.

**HOW MIGHT YOU DEFY IMAGINATION?**
If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.
**SENIOR REGULATORY AFFAIRS MANAGER**
**LIVE**
**What you will do**
In this vital role you will work to ensure that Amgen acquires and maintains all the required licenses in order to support clinical trials for investigational medicinal products as well as market commercially approved medicinal products.
Representing the EU region, you will be responsible for advising the GRT on regional considerations in developing strategy, and ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders.
+ Develop and execute regional regulatory product strategies, including precedence, risk management and contingency planning
+ Plan and manage regulatory submissions (e.g. clinical trial and marketing applications) for products within Amgen's portfolio in compliance with global filing plans and local regulatory requirements
+ Implement product related regulatory strategies, Regulatory Affairs processes and activity planning
+ Lead development of regional regulatory documents and meetings in accordance with GRT strategy
+ Provide regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plan)
+ Consistent with GRT strategy, advise on regulatory implications and requirements related to global clinical development plans and objectives
+ Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately
**Be part of our team**
You would be joining the European Regulatory team, part of the Global Regulatory Affairs function in Europe. You would be responsible for leading the European regulatory strategies and submissions for development and marketed products from first in human clinical trials to marketing authorisation, and throughout the products lifecycle.
This team is leading the regulatory activities for established products and also development assets.
**WIN**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional, are these qualifications and skills:
+ Degree educated in a scientific discipline
+ Extensive experience in regional regulatory environment
+ Proven track record of developing and executing regional regulatory strategy
+ In-depth understanding of the drug life cycle and development process from a regulatory perspective
+ In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals.
+ Ability to lead teams and work collaboratively in a dynamic environment
+ Proactive approach to problem solving
+ Ability to understand and communicate scientific/clinical information
+ Ability to anticipate regulatory agency expectations
+ Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development
**THRIVE**
**What you can expect of us**
As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
+ Growth opportunities to learn and move up and across our global organization
+ Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
+ Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
**LOCATION:** Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.
The position can also be located in our Lisbon office.
**APPLY NOW**
**for a career that defies imagination**
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
**careers.amgen.com**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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.

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