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Regulatory Affairs Senior Manager - CMC Europe 12 months - FREELANCE CONTRACT Home Base Negotiable Pay Rate LTD
We are looking for an experienced CMC Professional who will play a key role in developing and executing CMC regulatory strategies for new marketing authorisation applications and throughout whole product lifecycle for the European and extended European region.
Responsibilities will include:
• Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
- Oversee and review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries
• Manages Strategy and Execution for all regulatory submissions (e.g. clinical trial, variations, extensions and marketing applications) for products within the portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision.
• Leads development of regional regulatory documents (briefing books) and meetings in accordance with global regulatory strategy • Authoring and coordinating responses to questions across assigned products and countries.
• Provides regulatory direction on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, conditional/accelerated approvals, compassionate use and paediatric plan) • Gathering, consolidating and analysing regulatory intelligence for the EU region and support its application to product-specific activities • CMC RA subject matter expertise for a group of countries within the EU region
You must have extensive CMC experience within Europe as well as supporting and leading CMC strategy across the EU.
If you are interested in this role please contact Vik Patel at ARM on 07747215513 or email me on email@example.com with your cv and letter of interest.
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