Associate Director Regulatory Affairs

Cpl Life Sciences
London
6 months ago
Applications closed

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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

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