Associate Director Regulatory Affairs

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Client: Cpl Life SciencesLocation: Slough, United KingdomJob Category: Other-EU work permit required:

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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 role is crucial for that build-out and will significantly impact the future of the business.Job Description SummaryDirects the development and submission of product registration documents, progress reports, supplements, amendments, and periodic experience reports.Provides strategic product direction and negotiates with regulatory agencies.Interacts and negotiates with regulatory personnel to expedite approvals and address questions.Serves as a regulatory liaison throughout the product lifecycle, ensuring timely approvals of drugs, biologics, and medical devices.Acts as a regulatory representative to marketing, research teams, and government agencies.Advises on manufacturing changes, line extensions, labelling, and regulations.Coordinates and reviews reports for submission.Must-Haves6–10 years of regulatory affairs experience in pharma/biotech.European regulatory experience (EMA procedures, centralised filings, scientific advice).Experience with submissions like MAA, CTA, variations, RMPs (IND/global experience is a bonus).Proven 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-HavesBackground in Cardiometabolics or related therapeutic ..... full job details .....