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Regulatory Affairs CMC Manager

4 months ago

Uxbridge, United Kingdom Cpl Life Sciences Full time

Job Title: Regulatory Affairs CMC Manager

Job Type: 6-Month Contract (inside IR35)

Location: Uxbridge or Cambridge – 1 day on-site per month

Rate: £45 to £55 per hour (PAYE)


An exciting opportunity to join a leading global pharmaceutical company on a 6-month basis and sit within the Regulatory CMC team supporting global submissions. This role will drive global regulatory CMC strategies and support both developing and established drugs.


Responsibilities

  • This role will support two or more products from a global and international regulatory perspective.
  • Responsible for the generation of country-specific regulatory strategies and providing feedback to internal teams regarding submission plans and execution of the strategy for two or more products.
  • Interfaces with the affiliate offices for specific strategies or activities that impact a specific country.
  • Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
  • Review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries
  • Manages strategy and execution for all regulatory CMC submissions (e.g. late-stage clinical trials, variations, extensions and marketing applications) for products within the portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision.
  • Authoring and coordinating responses to questions across assigned products and countries.
  • Communicate regional needs for ensuring reliability of the supply chain and successful launch are well defined and implemented in collaboration with relevant regional stakeholders
  • Provides guidance for regulatory assessments of change control requests
  • Set project timeframes and priorities for products under their responsibility based on project objectives and ongoing assignments; raises resource constraints
  • Gathering, consolidating and analyzing regulatory intelligence for International Markets and supports its application to product-specific activities
  • Share regulatory information and implications with the stakeholders on an ongoing basis and provide advice on regional considerations
  • Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to the products.

Requirements:

  • A suitable degree in life sciences ideally chemistry.
  • At least 3+ years of experience in Regulatory CMC, with experience working on both small molecules and biologics.
  • Previous experience driving global regulatory strategies.
  • Experience authoring CMC sections including CTA, IND, IMPD, and MAAs.


For more information please reach out to lucy.kirkaldy@cpl.com

Please note you must be based in the UK and have the FULL right to work in the UK.