Senior Manager Regulatory Affairs
3 weeks ago
Maidenhead – 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.As Senior Regulatory Affairs Manager, you will: 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 . Previous experience leading interaction with health authorities (UK & EU) Ability to critically evaluate scientific data and identify regulatory risks and mitigation strategies.Author, review and strategic CMC abilities, such as API variations and clinical phase III experience is highly desirable
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Senior Manager Regulatory Affairs
3 days ago
Maidenhead, United Kingdom Blackfield Associates Full timeMaidenhead – 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...
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Senior Manager Regulatory Affairs
2 days ago
Maidenhead, Windsor and Maidenhead, United Kingdom Blackfield Associates Full timeMaidenhead – Hybrid. Full time, PermanentThis 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...
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Senior Manager Regulatory Affairs
3 days ago
Maidenhead, Berkshire, United Kingdom Blackfield Associates Full timeMaidenhead – 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...
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Regulatory Affairs Manager UKIE
1 week ago
Maidenhead, Windsor and Maidenhead, United Kingdom レオ ファーマ株式会社 Full time £60,000 - £90,000 per yearField of work: Regulatory & MedicalPosting Date: 11 Nov 2025Application deadline:26/11/2025Location:Maidenhead SL6 3UD, Berkshire, United KingdomContract type:PermanentJob ID:3940Shape the LEO Pharma of tomorrowLEO Pharma is looking for an experienced Regulatory Affairs professional to join our UK & Ireland team in a pivotal role ensuring our dermatology and...
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Regulatory Affairs Officer
2 days ago
Maidenhead, United Kingdom Noumed Life Sciences Full timeNoumed Life Sciences is an expanding pharmaceutical company based in Maidenhead, Berkshire focusing on cGMP, solid dosage generic pharmaceuticals. We offer a generous pension scheme, 23 days holiday, ample free parking, and an onsite gym. Due to significant growth across the business, we are looking for a Regulatory Affairs professional with moderate...
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Regulatory Affairs Officer
1 week ago
Maidenhead, United Kingdom Noumed Life Sciences Full time**Please note that this role is site based at our Manufacturing Plant in Maidenhead** Noumed Life Sciences is an expanding pharmaceutical company based in Maidenhead, Berkshire focusing on cGMP, solid dosage generic pharmaceuticals. We offer a generous pension scheme, 23 days holiday, ample free parking, and an onsite gym. Due to significant growth across...
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Regulatory Affairs Manager UKIE
1 day ago
Maidenhead, Berkshire, United Kingdom LEO Pharma UKIE Full timeApplication deadline: 24/12/2025 Location: Maidenhead SL6 3UD, Berkshire, United Kingdom Contract type: Permanent Job ID: 3940 Shape the LEO Pharma of tomorrow LEO Pharma is looking for an experienced Regulatory Affairs professional to join our UK & Ireland team in a pivotal role ensuring our dermatology and rare disease portfolio reaches patients safely and...
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Director of Regulatory Affairs
1 day ago
Maidenhead, Berkshire, United Kingdom LEO Pharma UKIE Full timeContract type: Permanent Shape the LEO Pharma of tomorrow LEO Pharma is looking for an experienced Regulatory Affairs professional to join our UK & Ireland team in a pivotal role ensuring our dermatology and rare disease portfolio reaches patients safely and in compliance with all regulatory requirements. At LEO Pharma, we are global leaders in medical...
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Associate Director, Regulatory Affairs Uk
2 days ago
Maidenhead, United Kingdom Biogen Full timeJob Description** About This Role** The Associate Director, Regulatory Affairs UK & Ireland will be responsible for leading and maintaining all country European Regulatory and R&D compliance activities across the product portfolio in line with the company’s strategy and the management of benefit/risk activities. You will work closely with the Head of the...
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Regulatory
1 week ago
Maidenhead, Windsor and Maidenhead, United Kingdom LEO Pharma UKIE Full time £60,000 - £120,000 per yearApplication deadline:26/11/2025Location:Maidenhead SL6 3UD, Berkshire, United KingdomContract type:PermanentJob ID:3940Shape the LEO Pharma of tomorrowLEO Pharma is looking for an experienced Regulatory Affairs professional to join our UK & Ireland team in a pivotal role ensuring our dermatology and rare disease portfolio reaches patients safely and in...
