224 Regulatory Affairs jobs in the United Kingdom

Job Title: Regulatory Affairs Consultant

Location: Maidenhead

Contract: 12 months / hybrid 3 days onsite

Hours: 37.5 per week

Rates: £50-60p/h

Job Description

SRG are looking for a regulatory affairs consultant to join a leading pharmaceutical company based in maidenhead. As part of this role, you will be Supporting lifecycle management of applicable products or submissions, management of paediatric investigation plans and clinical trial activities with the Medicines and Healthcare Products Regulatory Agency (MHRA).

Duties and Responsibilities

Overall responsibilities

With supervision and guidance from Line Manager;

• Acts as the primary Regulatory contact for identified portfolio.
• Develops robust regulatory strategies and timelines for those products throughout their lifecycle and provides regulatory information updates to cross functional team.
• Develops and maintains relationships with cross functional partners, as well as the Area Regulatory team to advocate the UK strategy objectives and timelines through the Area Regulatory Project Team.
• Serves as Health Authority liaison and interface for Health Authority meetings to obtain optimal outcomes for patients and company portfolio.
• Supports the business in planning for and execution of product launches, acquisitions and divestitures, as required.
• Regulatory intelligence and external landscape monitoring – provides regulatory impact assessment and establishes best practice

Main Accountabilities

• Supports Area and Brand teams as required to ensure local strategy is considered and that the key regulatory messaging is understood.

• Ensures submission and content of MHRA new and product lifecycle applications are made in accordance with appropriate timings and requirements

• Ensures appropriate and timely communication of regulatory and safety information as required by local regulation, company policies and procedures

• Keeps up to date with all appropriate Regulatory issues and operate as a ‘problem-solver’, to provide effective resolution of regulatory issues occurring within the UK, with an appreciation of business needs and priorities and will escalate to the Director, Regulatory Affairs as necessary.

• Builds business relationships with key internal stakeholders, including Europe region Regulatory Affairs, Medical Affairs, Market Access, Commercial and QA, as required to enable good cross-functional working.

• Stays abreast of all Regulatory intelligence updates and is proactive regarding implementation of necessary legislation/regulation changes.

Experience and Qualifications

• Life Sciences Degree or equivalent experience
• Varied experience within UK or EU Regulatory Affairs, including clinical trials, paediatric investigation plans, license lifecycle management
• Excellent communication skills, both verbal and written
• Effective influencing, tactical and presentation skills
• Effective project management experience
• Consultative and collaborative interpersonal style
• Excellent English language skills
• The ability to thrive in a changing environment and to re-prioritise workload to meet business needs.

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 //

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.

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

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

Job Description
CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women's and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at

Responsibilities
At CooperSurgical we are currently looking to recruit a
Regulatory Affairs Specialist
for an 18-month contract to cover maternity leave. You will be part of the global regulatory team, but primarily work with the UK RA based team. For this position you can be based in UK or EMEA and have an opportunity to work from home, remotely. This role will be reporting to the RA Manager based in UK.

Position
In the role of RA Specialist, you will be responsible for submissions globally but primary focusing on MEA and LATAM. You have strong experience with global product registration and re-registration and adept at liaising with the right people to collect and gather the relevant documentation and files. You will be responsible for completing annual renewals and following up on deadlines and tasks, to meet submission timelines. Preferable you have worked with single use sterilized products and electrical, electronic devices, and be familiar with the appropriate standards and regulations.

As a person you thrive in a dynamic and busy environment which provides you with an opportunity to use your planning and prioritization skills to meet deadlines and progress registration projects. You will work closely together with other RA professionals and cross functional stakeholders in this international organization.

The position as RA Specialist is vital for the success and growth of CooperSurgical.

Your Key Responsibilities

• Lead regulatory activities, reviewing, maintaining, and submitting files and legalized documentation
• Facilitate collection of data for international registrations
• Complete administrative RA tasks
• Monitor for any change in META & LATAM medical device regulations
• Liaise with stakeholders globally

Qualifications

• MSc in relevant field Engineer, Bio Science, Technical or alike
• • 2-3 years of experience from a similar role -preferable
• Global submission experience
• Structured and systematic work ethic
• Strong communication and problem-solving skills
• Proficient level in MS office
• Fluent English (spoken and written) is mandatory
• A can-do attitude and proactive approach