Regulatory Affairs CMC Manager
2 weeks ago
Regulatory Affairs CMC ManagernJob Type:
6-Month Contract (inside IR35)nLocation:
Uxbridge or Cambridge – 1 day on-site per monthnRate:
£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.
ResponsibilitiesnThis role will support two or more products from a global and international regulatory perspective.nResponsible 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.nInterfaces with the affiliate offices for specific strategies or activities that impact a specific country.nEnsuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategiesnReview the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countriesnManages 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.nAuthoring and coordinating responses to questions across assigned products and countries.nCommunicate regional needs for ensuring reliability of the supply chain and successful launch are well defined and implemented in collaboration with relevant regional stakeholdersnProvides guidance for regulatory assessments of change control requestsnSet project timeframes and priorities for products under their responsibility based on project objectives and ongoing assignments; raises resource constraintsnGathering, consolidating and analyzing regulatory intelligence for International Markets and supports its application to product-specific activitiesnShare regulatory information and implications with the stakeholders on an ongoing basis and provide advice on regional considerationsnMaintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to the products.nRequirements:nA suitable degree in life sciences ideally chemistry.nAt least 3+ years of experience in Regulatory CMC, with experience working on both small molecules and biologics.nPrevious experience driving global regulatory strategies.nExperience authoring CMC sections including CTA, IND, IMPD, and MAAs.
For more information please reach out to note you must be based in the UK and have the FULL right to work in the UK.
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