Regulatory Affairs Senior Manager - International CMC
Uxbridge or Cambridge - Hybrid
£75,000 - £85,000
Compass Life Sciences have partnered with a global leading Biotech to support them in their search to appoint a Regulatory Affairs Senior Manager - International CMC, to join their International Regulatory CMC Centre team. The successful applicant will be someone who can develop and execute CMC regulatory strategies for new Marketing Authorization Applications, Clinical Trial Applications, and Post-approval Variations dossiers that comply with international country/region regulatory standards. Additionally, this role will require close collaboration with the Centre Director for International Regulatory CMC, International CMC leads as well as country local Regulatory representatives to ensure efficient execution of the regional submission plans.
Responsibility for the generation and execution of international country specific regulatory strategies
Accountable for management of regional CMC filings from marketing authorisation to post-approval supplements, renewals, and responses to questions across assigned products and countries for products within the portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision.
Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered
Review and preparation of M2 and 3 components for International Clinical Trial Applications, Marketing Applications, and post-market supplements/variations
Authoring and coordinating responses to questions across assigned products and countries.
Gathering, consolidating, and analysing regulatory intelligence for International Markets and supports its application to product-specific activities
Project management of submissions and monitoring status of applications
Provides guidance for and performs regulatory assessments of change control requests
Provide regional/country, product & regulatory expertise, and clarification on International CMC RA requirements
Knowledge & Experience
Master's or bachelor's degree or equivalent
Regulatory Affairs experience
Creation and execution of regional regulatory strategies
CMC specific regulatory knowledge and experience in the manufacture/testing of pharmaceutical products
Direct experience with international market applications - MAAs or variations
Good understanding or direct experience of ex US filings
Excellent communication skills with ability to communicate across all levels
Project management skills with ability to work well with others in demanding situations
Ability to work in a fast-paced environment
Current knowledge and application of CMC hot topics and knowledge of international legislation and guidance for biotechnology products
Strong MS Office skills
Competitive salary reflecting experience and ability. Benefits include a generous car allowance, Long Term Incentives (LTI) and Bonus. This role offers the ability to work flexibly from home with regular office work from one of two next generation workspaces.
If you are interested in learning more, please contact me directly today as we are looking to appoint as soon as possible. For further information please contact me at firstname.lastname@example.org, or phone +44 (0)239 4211142.
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