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