Regulatory Affairs Manager
4 weeks ago
UK CW Regulatory Affairs Manager (Inside IR35)
This role will support one or more products from a regional 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 one or more products.
* Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
* Manages strategy and execution for all regulatory CMC submissions (e.g. late stage clinical trials, variations, extensions and marketing applications) for products within company's portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision.
* 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; 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 company products.
* Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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