Senior Manager/Director of Regulatory Affairs

3 weeks ago

United Kingdom i-Pharm Consulting Full time

Regulatory Affairs Manager Location : Contract Length: 6-month (View to extend)
Monday - Friday
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.
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 the client'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 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 the client's products.
Performs regulatory research to obtain relevant histories, precedence, and other information relevant to regional product advancement.

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