190 Government Affairs Consultants jobs in the United Kingdom

Role - Regulatory Affairs Manager

Duration - 12 Months

Location - Remote

Outside IR35

The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RAM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Responsibilities:

• Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
• Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
• Submission delivery strategy of all dossiers and all application types per market and /or region.
• Review of documents (e.g. response documents, study protocols, PSRs, etc.).
• Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
• Use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
• Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and with experience, increasingly more complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Coordinate the input, maintenance and revision in the Planit project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
• Identify regulatory risks and propose mitigations to Lead RPM and cross functional teams.
• Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs and/or alliance partners where relevant.
• Provide coaching, mentoring and knowledge sharing within the RAM skill group.
• Contribute to process improvement.

Minimum Requirements –Education and Experience

• Relevant University Degree in Science or related discipline
• Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
• Thorough knowledge of the drug development process
• Managed regulatory deliverables at the project level
• Strong project management skills
• Leadership skills, including experience leading multi-disciplinary project teams

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements

ARC's purpose is to expedite access to precision medicine clinical trials for patients globally. We fulfil our purpose through our dedicated team of experts with unparalleled domain knowledge, and the important relationships we have developed with our global clients.

We are a Belfast-based Clinical Research Organisation that specialises in delivering compliance excellence for companies in the precision medicine sector. We support many of the world's leading pharmaceutical R&D companies in implementing unapproved diagnostics in their clinical development programmes for patient selection or stratification, working as a strategic and integrated expert partner, taking full sponsor ownership of the IVD study being conducted in parallel with our clients' IND/IMP trial.

ARC's team of experts cover IVD regulatory compliance, study design and approvals, quality assurance including vendor due diligence and management along with a team of clinical research experts who manage the IVD study, ensuring it is conducted in compliance with local and global GCP, and that the biomarker data is robust and reliable.

To further support our growing client base and to expedite patient access to life-saving experimental medicines, ARC has developed and launched our SaaS platform, ARC360. ARC360 is transforming how organisations access regulatory intelligence and tailor study-specific information for using in vitro diagnostics to select and manage patients in IND trials. Powered by cutting-edge technologies and supported by a team of regulatory, quality, and clinical operations experts, ARC360 is designed to accelerate the initiation of complex clinical trials.

Job Description

To be an integral member and significant contributor to project team(s) in the development and delivery of global compliance solutions to client companies, ensuring that client objectives are met and exceeded at all times. This will require the utilisation of a platinum standard approach to regulatory research, internal and external stakeholder satisfaction as well as an innate work ethic and attention to detail that is aligned with the company’s core values.

• Support the work of the company and project teams in the provision of specialised regulatory and quality assurance expertise to client companies, ensuring client expectations and interests are met.
• Research and prepare elements of regulatory submission documents on behalf of client companies, including but not limited to study risk determination requests, IDE submissions, 510(k), PMA, CE Technical Files and Design Dossiers, PMDA Briefing Documents and Submissions etc.
• Assist wider team in understanding the regulatory requirements for an investigational device in the set-up, management & conduct of IVD performance studies worldwide.
• Manage and keep up to date information relating to regulatory requirements for IVD performance studies and maintain the company’s web-based clinical trial planning tool.
• Conduct gap analyses on behalf of client companies and prepare associated reports
• Contribute to the preparation of global guidance documents and white papers.
• Contribute to the preparation of other regulatory documents on behalf of client companies (e.g., Performance Evaluation Plans/Reports, Investigator Brochures, etc).
• As required, take advantage of professional networking opportunities to promote the company and its services to appropriate parties.
• Undertake continuing professional development activity to ensure awareness of current quality and regulatory standards.
• Contribute to ARC company culture initiatives to maintain a positive and engaging workforce.
• Any other duties, within reason and capability, as determined by company management.

Essential Criteria

• Engineering or Scientific honours degree or equivalent (10+ years) relevant industry experience
• 5+ years’ experience of working in a medical device/IVD manufacturing or regulatory environment
• Experience with IVD/CDx design and development, from feasibility to approval
• Knowledge of regulations in key global markets as they pertain to IVD and/or CDx devices (e.g. EU/US)
• Experience of leading global regulatory submissions (e.g. EU/FDA)
• Experience developing and maintaining technical documentation (IVDD/IVDR) or design history file documentation (FDA)
• Experience developing global regulatory strategies for IVD devices

“We are an equal opportunity employer; applications are welcome from all and appointment will be made on the basis of merit.”

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