733 Regulatory Affairs Manager jobs in the United Kingdom

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 //

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 Consultant (Permanent) – SaMD and AI Focus

Fully Remote UK or Ireland - Must be based in the UK / Ireland with the right to work

Imagine starting your day from the comfort of your home office, connecting with a MedTech startup on the cusp of launching their first AI-powered diagnostic platform. They’re bright, ambitious, and full of ideas, but need someone with your regulatory know-how to steer their path to market.

By lunchtime, you’re deep in a design review for another client, translating complex engineering data into compliant, audit-ready documentation. Your afternoon might be spent advising a founder on clinical evaluation strategy or reviewing a technical file for FDA submission.

Every day brings something different, but each moment builds towards the same goal - helping innovative MedTech companies get their products safely and successfully into global markets.

You’ll be part of a small but growing consultancy that specialises in supporting SaMD and digital health developers across the UK and EU. Their collaborative, knowledge-sharing culture means you’ll never work in isolation, and you’ll have the chance to grow your expertise alongside other talented professionals who share your passion for innovation.

The Opportunity

• Variety and Impact: Work on diverse, high-impact projects spanning early-stage startups to established SMEs developing cutting-edge SaMD and AI-driven devices.
• Flexibility: A fully remote position giving you the freedom to work from anywhere in the UK or Ireland.
• Growth and Leadership: An opportunity to grow and lead a developing division within a consultancy expanding its SaMD and digital health offering.
• Technical Depth: The chance to round off and fine-tune your specialist technical skills in SaMD while tackling complex regulatory challenges.
• Career Development: Join a consultancy with a proven record of internal development and promotion.
• Collaborative Environment: Work alongside experienced specialists who value honesty, integrity, and humour in their daily interactions.
• Purpose: Play a direct role in bringing meaningful health technologies to patients worldwide.

How You’ll Make an Impact

• Guide clients through regulatory pathways for EU MDR, IVDR, and FDA submissions.
• Prepare and review technical documentation, design dossiers, and clinical evaluation reports.
• Support design and product risk management activities from concept to post-market phases.
• Advise on post-market surveillance and vigilance processes.
• Help shape early-stage development strategies for new SaMD and AI-based technologies.
• Ensure compliance with global regulatory requirements and contribute to client success stories.

The Kind of Person Who Will Thrive Here

• Proven experience in regulatory affairs, ideally within SaMD, AI, or digital health.
• Strong understanding of EU MDR, IVDR, and FDA 510(k) frameworks.
• Background in engineering, life sciences, or a related technical discipline.
• Excellent communication skills and a personable, solutions-focused approach.
• The confidence to manage multiple projects while providing clear, practical regulatory advice.

Who You’ll Be Joining

This is a small but expanding regulatory consultancy that has built its reputation on trust, quality, and deep technical expertise. The team is growing to meet demand from MedTech innovators developing next-generation digital and software-based medical devices. Their collaborative culture encourages learning, career development, and a sense of shared purpose - helping clients overcome regulatory hurdles while enabling safe, effective technologies to reach patients faster.

Senior Regulatory Affairs Manager – Europe

Slough – Hybrid. Full time, Permanent

This position supports and coordinates regulatory activities for both specialty and generic pharmaceutical products across Europe. The role involves strategic input into development programs, preparation and submission of regulatory documentation, and post-approval lifecycle management. You will work cross-functionally with internal teams and external partners to ensure timely and compliant submissions to EMA and national authorities.

Key Responsibilities:

• Lead regulatory strategy development for new and existing products, including De-centralised/orphan and generic submissions.
• Review non-clinical and clinical data packages for regulatory adequacy and compliance.
• Conduct due diligence across CTD Modules 1–5 and review sections of Marketing Authorisation Applications (MAAs).
• Coordinate registration and maintenance of assigned generic products.
• Support regulatory authority interactions, including scientific advice procedures.
• Maintain regulatory databases and document management systems.
• Guide junior staff and contribute to process improvements within the regulatory function.
• Ensure alignment with EU regulatory requirements for product launch and lifecycle activities.

Required Experience & Qualifications:

• Strong, clear evidenced experience with European regulatory frameworks and submission pathways (DCP, MRP, national procedures).
• Proven experience in regulatory strategy development for specialty and generic products- minimum 7 years industry experience
• Hands-on experience with post-approval activities, variation strategies, line extensions and due diligence .
• Familiarity with regulatory tools and platforms (eCTD, CESP, MHRA portal, Eudralink).
• Ability to critically evaluate scientific data and identify regulatory risks and mitigation strategies.
• Degree or higher qualification in Pharmacy, Life Sciences, or a related field.
• Excellent communication, project management, and cross-functional collaboration skills.
• Experience managing regulatory timelines and approvals in a fast-paced environment.

All applicants must hold valid right to work as sponsorship is unavailable.

Must be located within a commutable distance to SL1 and comfortable working from the office at least 3 times per week.

Regulatory Manager (Permanent) – Medical Devices

Leicester (Hybrid) – Office-based culture with flexibility (approx. two days from home)

Applicants must have the right to work; sponsorship / future sponsorship cannot be supported.

This is an opportunity to step into a visible, commercially connected Regulatory role where you’ll shape market expansion for a leading UK manufacturer of Class IIb medical devices .

You’ll join a company with a diverse portfolio of consumer medical products sold through major high-street retailers and international partners. The business is privately owned, well-resourced, and operates with the spirit of an SME.

Due to steady growth, they are creating a new position to take the lead on global product registrations and drive market access across Asia, Africa, and other Rest-of-World regions .

You’ll also support ongoing MDR transition work alongside an experienced Senior Regulatory Manager.

The Opportunity

Visibility and Ownership:

Take responsibility for defining and executing global regulatory submissions while working closely with senior leadership.

Strategic Input:

Work with the commercial team to decide the most effective route to market — whether to register products via local distributors or retain legal manufacturer responsibility directly.

Market Expansion:

Lead regulatory submissions and product registrations worldwide, ensuring compliant and timely approvals across Rest-of-World territories.

Collaboration:

Partner with quality, manufacturing, and commercial teams to maintain compliance and enable new launches.

Career Growth:

Join at a time of expansion, with scope to progress towards the Head of Compliance role in the medium term.

Culture and Flexibility:

Enjoy an open, down-to-earth working environment with genuine flexibility.

How You’ll Make an Impact

• Lead regulatory submissions and product registrations across Asia, Africa, and other Rest-of-World markets.

• Advise on market entry strategy, helping assess regulatory complexity, cost, and timelines.

• Provide regulatory input for new product acquisitions, determining legal manufacturer and distributor responsibilities.

• Manage and support two Regulatory Associates.

• Contribute to MDR transition work where required.

• Collaborate across functions to ensure continued compliance and readiness for new product launches.

Who Will Thrive Here

• Experienced in medical device regulatory affairs , with multi-country registration experience .

• Commercially minded with the ability to balance compliance requirements with business goals.

• Skilled at building relationships and influencing cross-functional teams.

• Enjoys working in smaller, collaborative settings where responsibilities are broad and shared.

• Holds a scientific or technical degree (chemistry or related discipline preferred).

• Experience with sterile products or cosmetics is a plus, but medical devices expertise is key.

Who You’ll Be Joining

You’ll be part of a well-established UK manufacturer known for quality and innovation in medical devices and consumer health products.

With around 100 employees across two sites, the company combines the stability of a larger organisation with the agility and informality of a smaller team .

They’re strengthening their compliance frameworks and expanding into new international markets.

Collaboration, flexibility, and mutual support are at the heart of how they work.

Why This Role Stands Out

• Hybrid working – typically three days in the Leicester office.

• Supportive, people-focused culture where everyone contributes.

• Real career growth potential within a respected UK medical device company.

Apply today or contact

Regulatory Affairs manager – Medical Devices

A new role in Regulatory Affairs has become available at an exciting medical devices organisation who have products undergoing clinical trials. The role focuses on FDA and UK/EU submissions

As an experienced Regulatory Affairs professional, you’ll manage and prepare regulatory submissions (e.g., variations, renewals, new market applications) and ensure compliance with U.S. (FDA) and European (EMA) regulations. Key responsibilities include strategic planning, cross-functional coordination with manufacturing, quality assurance, regulatory writing and document review, and liaising with health authorities.

The company has exciting medical device products currently undergoing clinical trials. Head office is based in Oxfordshire.

Key Responsibilities

• Submission Strategy:

Developing strategic plans for regulatory submissions, including variations, renewals, and new market applications.

• Document Preparation:

Writing, reviewing, and ensuring the accuracy and compliance of submission documents, such as Chemistry, Manufacturing, and Controls (CMC) data, study reports, and other regulatory materials.

• Regulatory Compliance:

Ensuring all submissions and regulatory activities meet the requirements of the FDA (U.S.) and European Medicines Agency (EMA).

• Cross-Functional Coordination:

Collaborating with internal teams (manufacturing, quality assurance, quality control, etc.) and external partners to gather necessary information for submissions.

• Authority Interaction:

Communicating with health authorities (e.g., FDA, EMA) regarding submissions, queries, and regulatory matters.

• Post-Approval Maintenance:

Managing ongoing regulatory activities such as post-approval variations, annual reports, and changes to product manufacturing.

Required Skills & Qualifications

• Regulatory Knowledge: In-depth understanding of FDA and EU regulatory requirements for pharmaceutical products or medical devices.

• Technical Skills: Proficiency in regulatory document management systems and MS Office applications.

• Communication: Strong written and verbal communication skills in English.

• Project Management: Ability to manage multiple projects, meet deadlines, and prioritize tasks effectively.

• Collaboration: A collaborative team player with cultural awareness and adaptability.

This is an exciting opportunity at a growing medical devices organisation. The facility is based in Oxfordshire and offers hybrid working opportunities.

We look forward to receiving your application.

CY Partners is acting as an Employment Business / Agency in relation to this vacancy.

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 //

Senior Regulatory Affairs Manager – Europe

Slough – Hybrid. Full time, Permanent

This position supports and coordinates regulatory activities for both specialty and generic pharmaceutical products across Europe. The role involves strategic input into development programs, preparation and submission of regulatory documentation, and post-approval lifecycle management. You will work cross-functionally with internal teams and external partners to ensure timely and compliant submissions to EMA and national authorities.

Key Responsibilities:

• Lead regulatory strategy development for new and existing products, including De-centralised/orphan and generic submissions.
• Review non-clinical and clinical data packages for regulatory adequacy and compliance.
• Conduct due diligence across CTD Modules 1–5 and review sections of Marketing Authorisation Applications (MAAs).
• Coordinate registration and maintenance of assigned generic products.
• Support regulatory authority interactions, including scientific advice procedures.
• Maintain regulatory databases and document management systems.
• Guide junior staff and contribute to process improvements within the regulatory function.
• Ensure alignment with EU regulatory requirements for product launch and lifecycle activities.

Required Experience & Qualifications:

• Strong, clear evidenced experience with European regulatory frameworks and submission pathways (DCP, MRP, national procedures).
• Proven experience in regulatory strategy development for specialty and generic products- minimum 7 years industry experience
• Hands-on experience with post-approval activities, variation strategies, line extensions and due diligence .
• Familiarity with regulatory tools and platforms (eCTD, CESP, MHRA portal, Eudralink).
• Ability to critically evaluate scientific data and identify regulatory risks and mitigation strategies.
• Degree or higher qualification in Pharmacy, Life Sciences, or a related field.
• Excellent communication, project management, and cross-functional collaboration skills.
• Experience managing regulatory timelines and approvals in a fast-paced environment.

All applicants must hold valid right to work as sponsorship is unavailable.

Must be located within a commutable distance to SL1 and comfortable working from the office at least 3 times per week.