The CMC Regulatory Manager– External Manufacturing will support the preparation of CMC sections of regulatory post approval filings including coordination, authoring and review of all Module 3 and Module 1 variations and associated RTQs. They will working closely with Regulatory CMC management, external vendors and partner companies to ensure alignment of strategy.
- Support the preparation of CMC sections of regulatory submissions and obtain agreement on the regulatory strategy from all stakeholders.
- Participate in the development of the regulatory strategy for new variations, with support from the Head of Regulatory CMC, External Manufacturing.
- Ensure all CMC dossier data remain relevant, compliant, current, and an accurate reflection of all CMC-related aspects of the products, processes and practices.
- Ensure timely submission-readiness of CMC dossiers for products assigned. Coordinate all related CMC Regulatory activities including responses to questions from Regulatory Agencies.
- Monitor and report on CMC Regulatory activities and process performance for the allocated products; identify areas for improvement, implement and monitor subsequent actions.
- Ensure optimized communication with vendors and partners involved in the CMC Regulatory process.
- Ensure proper execution of the CMC Regulatory process and related activities.
- Ensure the Head of Regulatory CMC, External manufacturing is provided with accurate and up-to-date CMC Regulatory information and work with Head of Regulatory CMC, External manufacturing to alert the QP to any information that is needed to ensure proper and fully compliant release for each market.
Experience & Qualifications:
- MSc in a life sciences discipline.
- 5 years of pharmaceutical experience with at least 3 years in the preparation and submission of CMC filings (modules 3 and 2.3) for European markets.
- Small molecule experience is essential. Biological experience or a desire to develop in Biological CMC is desired.