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Regulatory Affairs Manager
4 months ago
Position: Regulatory Affairs Manager
Location: Uxbridge (UK)
Contract Length: 6-month (View to extend)
Work Structure: Monday - Friday
Pay Rate: Available on request - (Inside IR35)
The new Regulatory Affairs Manager must be an individual who has proven experience within a CMC (Chemistry, Manufacturing & Controls) focused environment.
The client is a leading global biotechnology company that specializes in discovering, developing, manufacturing, and delivering human therapeutics. Since being founded over 40 years ago, they have grown to be one of the world's largest independent biotech firms.
Regulatory Affairs Manager - 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 Amgen 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 countriesManages strategy and execution for all regulatory CMC submissions (e.g. late-stage clinical trials, variations, extensions, and marketing applications) for products within Amgen's 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 Sets project timeframes and priorities for products under their responsibility based on project objectives and ongoing assignments; raises resource constraints Gathering, consolidating, and analysing 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 Amgen products.Performs regulatory research to obtain relevant histories, precedence, and other information relevant to regional product advancement.
If you have the experience required for this challenging yet rewarding role, please submit your application including a CV and cover letter to - or press the "Apply" button below.
