Senior Manager Regulatory Affairs

3 days ago

Maidenhead Berkshire, United Kingdom Blackfield Associates Full time

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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