Social network you want to login/join with:Associate Director Regulatory Affairs, London

Client: Cpl Life SciencesLocation: London, United KingdomJob Category: OtherEU work permit required: YesJob Views:

3Posted:

26.08.2025Expiry Date:

10.10.2025Job Description:

I''m working on a new Associate Director Regulatory Affairs role with a global pharmaceutical manufacturing organisation based in London. Regulatory is a key function being scaled within the organisation. This hire is crucial for that build-out and will significantly impact the future of the business.Job Description Summary

Directs the development and submission of product registration, progress reports, supplements, amendments, and periodic experience reports.Provides strategic product direction and negotiates with regulatory agencies.Interacts and negotiates with regulatory agency personnel to expedite approvals and address questions.Serves as a regulatory liaison throughout the product lifecycle, ensuring rapid approval of new drugs, biologics, and medical devices, and maintaining approved status of marketed products.Acts as regulatory representative to marketing, research teams, and government agencies.Advises development and marketing teams on manufacturing changes, line extensions, labeling, and regulations.Coordinates, reviews, and prepares reports for submission.Must-Haves

6–10 years of regulatory affairs experience in pharma/biotech.European regulatory experience (EMA procedures, centralised filings, scientific advice).Experience with submissions such as MAA, CTA, variations, RMPs (IND/global experience is a bonus).Evidence of strategic contribution to regulatory development planning.Ability to represent regulatory in cross-functional teams.Strong communication skills to liaise with health authorities and global counterparts.Nice-to-Haves

Background in Cardiometabolics or related therapeutic areas.

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