Regulatory jobs in GB offer a dynamic career path for professionals interested in 452 Regulatory jobs in the United Kingdom
Regulatory Affairs Officer
London, London
SUN PHARMA
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
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Regulatory Affairs Manager
Cambridgeshire, Eastern
Walker Cole International
Posted today
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Job Description
A leading medical device and IVD manufacturer based in Cambridgeshire is looking for a Regulatory Affairs Manager . This company develops and supplies innovative diagnostic solutions used worldwide. As a Regulatory Affairs Manager , you’ll play a key role in ensuring products meet global regulatory, safety, and quality standards from early development through to post-market support. You’ll lead regulatory strategy, guide compliance initiatives, and support the commercialisation of new and existing products across international markets. Your responsibilities as the Regulatory Affairs Manager will include: Leading and delivering regulatory strategies for new product launches, updates, and ongoing compliance. Overseeing global submission preparation, approval processes, and regulatory documentation. Acting as the regulatory lead on cross-functional project teams, offering clear, solution-driven advice. Managing vigilance, recalls, risk management, and post-market surveillance activities. Reviewing and approving labelling, promotional materials, and technical documentation for compliance. Monitoring global regulatory changes and ensuring continued product conformity. Supporting the Quality Management System (QMS) and maintaining ISO 13485 compliance. Mentoring and developing junior regulatory team members. Acting as the Person Responsible for Regulatory Compliance (PRRC) under IVDR, where qualified. To be successful as the Regulatory Affairs Manager, you will need to demonstrate: A degree (or equivalent) in Life Sciences or a related discipline. At least 8 years of experience in IVD and/or medical device regulatory affairs, preferably EU-focused. A recognised qualification in Regulatory Affairs and evidence of continued professional development. Proven ability to manage multiple projects and regulatory submissions independently. Strong knowledge of ISO 13485 and global medical device regulatory frameworks. In addition, the following will be advantageous for a Regulatory Affairs Manager: Experience with FDA (21 CFR Part 820) and global regulatory bodies. Background in post-market surveillance, vigilance, and recall management . Regulatory Affairs Manager | Medical Devices | IVD | ISO 13485 | IVDR | 21 CFR 820 | Regulatory Compliance | Post-Market Surveillance | Risk Management | Vigilance | Cambridge Jobs
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Regulatory Affairs Manager
Oxford, South East
CY Partners
Posted today
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Job Description
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.
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Regulatory Affairs Consultant
London, London
Storke
Posted today
Job Viewed
Job Description
Company Description Storke hosts AI agents for Medical Device Regulatory Affairs; designed to automate the most taxing workflows for medical device companies. Our AI agents handle documentation, submissions, and compliance tracking, reducing months of manual effort to accelerate time-to-market. By transforming regulatory affairs from bottleneck to competitive advantage, Storke enables companies to focus on innovation whilst ensuring stringent compliance standards are met. Role Description This is a contractual (3 Month) part-time role that is remote for a Regulatory Affairs Consultant. This is a very flexible role, requiring less than 10 hours of work per month. The Regulatory Affairs Consultant will be responsible for refining submission documents, whilst ensuring the quality of documentation is of industry standard. Clear focus will currently be on MHRA Class I, Class IIa/IIb submissions. Please note that you will not be writing or creating documents, but reviewing them Generous compensation for time spent, w e bill hourly! Qualifications Skills in Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs Experience in primarily managing MHRA Class I,IIa/IIb submissions, Class III is a plus but not a necessity Project Management skills Excellent attention to detail and analytical skills Ability to work collaboratively Ability to meet deadlines Experience in the healthcare or pharmaceutical industry is a plus
This advertiser has chosen not to accept applicants from your region.
3
Regulatory Affairs Officer
London, London
SUN PHARMA
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
This advertiser has chosen not to accept applicants from your region.
4
Regulatory Affairs Consultant
London, London
Storke
Posted today
Job Viewed
Job Description
Company Description Storke hosts AI agents for Medical Device Regulatory Affairs; designed to automate the most taxing workflows for medical device companies. Our AI agents handle documentation, submissions, and compliance tracking, reducing months of manual effort to accelerate time-to-market. By transforming regulatory affairs from bottleneck to competitive advantage, Storke enables companies to focus on innovation whilst ensuring stringent compliance standards are met. Role Description This is a contractual (3 Month) part-time role that is remote for a Regulatory Affairs Consultant. This is a very flexible role, requiring less than 10 hours of work per month. The Regulatory Affairs Consultant will be responsible for refining submission documents, whilst ensuring the quality of documentation is of industry standard. Clear focus will currently be on MHRA Class I, Class IIa/IIb submissions. Please note that you will not be writing or creating documents, but reviewing them Generous compensation for time spent, w e bill hourly! Qualifications Skills in Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs Experience in primarily managing MHRA Class I,IIa/IIb submissions, Class III is a plus but not a necessity Project Management skills Excellent attention to detail and analytical skills Ability to work collaboratively Ability to meet deadlines Experience in the healthcare or pharmaceutical industry is a plus
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5
Regulatory Affairs Consultant
Maidenhead, South East
SRG
Posted today
Job Viewed
Job Description
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.
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Regulatory Affairs Manager
London, London
Walker Cole International
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 //
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7
Regulatory Affairs Manager
Slough, South East
Blackfield Associates
Posted today
Job Viewed
Job Description
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.
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8
Regulatory Affairs Manager
London, London
Walker Cole International
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 //
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