Associate Director Regulatory Affairs

I'm working on a new Associate Director Regulatory Affairs role with a fantastic global pharmaceutical manufacturing organisation based in London. Regulatory is one of the key functions being scaled within the organisation. This hire is a cornerstone role in that build-out and will have a massive impact on the future of the business. Job Description Summary Directs the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labelling, appropriate regulations and interpretations. Coordinates, reviews, and may prepare reports for submission Must-Haves 6–10 years regulatory affairs experience in pharma/biotech. European regulatory experience (EMA procedures, centralised filings, scientific advice). Submissions across MAA, CTA, variations, RMPs (IND/global a bonus). Evidence of strategic contribution to regulatory development planning. Ability to represent regulatory in cross-functional teams. Strong communicator, able to liaise with HA and global counterparts. Nice-to-Haves Direct EMA/MHRA negotiation experience. IND or global dossier exposure. Background in Cardiometabolics or related TAs. If this is something you'd be interested in, get in touch with jamie.keith@cpl.com

Location: London,, GB

Posted Date: 9/8/2025