Regulatory CMC Senior Manager
- Experience Level
- Senior Management
My client are a global pharmaceutical company that develops & markets innovative medicines for patients with life-threatening conditions. They are well-financed and have significant resources committed from our equity sponsors for tack-on deals and larger transaction opportunities. This company are accelerating their global expansion and establishing new therapeutic franchises, evolving as a leader in providing highly efficacious therapeutic solutions to patients at affordable prices.
If you are looking to be a part of a dynamic, global, fast-growing organisation, have a positive attitude, willing to develop yourself, and are energised by being a part of improving the health of others, they are the perfect match for you. By joining as the SENIOR RA CMC Manager your position will be broad, communication between departments will be fast and effective and you will have significant responsibility and autonomy for your work and contributions.
The SENIOR RA CMC Manager will work with other RA CMC team members and be a member of multifunctional teams (company internal team members and third party CMO’s). They will provide support for the needs of the Company from a regulatory point of view to ensure successful applications with health agencies in the most efficient way.
IN THIS ROLE YOU WILL:
- Represent the RA team as CMC expert on project teams and lead global RA CMC strategies for CMC related projects (product development, technology transfers etc)
- Be responsible for the timely completion of well organised, scientifically sound regulatory CMC submissions, to include agency meeting packages, DMFs, INDs, CTAs, NDAs and MAAs, amendments and supplements, responses to requests for information, etc. Writing of Module 3 sections/participation in submission preparation is expected.
- Maintain an in depth level of understanding of the assigned compounds, their characteristics, manufacturing aspects and specifications/analytical methods
- Review technical reports and summary documents (chemistry, manufacturing and quality) for adherence to regulatory guidelines, strategies, and commitments.
- Contribute to writing expert summaries of CMC submissions
- RA review Change Controls and co-ordinate with QA to ensure successful implementation
- Manage preparation for CMC meetings with Health Authorities
- Maintain an understanding and awareness of existing and forthcoming legislation and guidelines related to CMC
- Provide regulatory expertise and policy support for GMP
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