Regulatory Consultant – CMC (CMC with small molecule products)
Updated: TodayLocation: London, LND, United KingdomJob ID: 25108623
Description
Supports the execution of multi-product global regulatory CMC for marketed small molecule products. Contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support to cross‑functional teams.
Key Duties and Responsibilities
- Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on Middle East and North Africa.
- Reviews CMC sections of regulatory submissions and manages interactions and responses with regulatory agencies for small molecule products.
- Works with regulatory colleagues to develop global regulatory CMC strategies and submissions.
- Participates effectively on cross‑functional teams and may serve as the primary regulatory CMC contact for assigned products and projects.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, or job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. All employment is conditional upon compliance with the legislation of each country in which it operates, including the implementation of the EU Equality Directive, and the Americans with Disabilities Act, including the provision of reasonable accommodations when appropriate.
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