Senior Regulatory Affairs Manager CMC – 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 and due diligence reviews. 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 activities is essential.
* 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.