Regulatory Affairs - CMC (d/f/m)

- Globally operating pharmaceutical company - Temporary assignment for 12-24 months **About Our Client** For our client, a globally renowned pharmaceutical company in the Basel area, we are seeking a Regulatory Affairs CMC professional to strengthen the team in 2026 in support of Phase 3 development activities. The contract duration is 12-24 months and is open to candidates with 5+ years of relevant experience across different seniority levels. Depending on the selected candidate's performance and motivation, the possibility of an extension or a permanent take over. **Job Description** Depending on the candidate`s seniority, the incumbent will provide Regulatory Affairs leadership or support for CMC aspects of Phase 3 development, ensuring quality data are appropriately positioned for late-stage clinical use and future licensure (small molecules drugs). - Lead / Support development and execution of Phase 3 CMC regulatory strategy - Author / Review CMC sections of IND amendments, CTA updates, and BLA/MAA modules - Manage / Coordinate responses to health authority CMC questions - Lead / Support health authority interactions (Type C, Scientific Advice, pre-BLA) - Ensure / Contribute to alignment of specifications, control strategy, and stability claims with regulatory expectations - Lead / Support assessment of regulatory impact of manufacturing or analytical changes - Define / Support post-approval CMC commitments and lifecycle planning - Represent / Support representation of CMC topics in cross-functional governance **The Successful Applicant** **In order to be considered for the role, the selected candidate must have:** - Degree in Life Sciences disciplines - Relevant experience inpharma RegulatoryCMC phase 3 (small molecules): - ~5-7 years: Drafts submissions, supports HA interactions, manages discrete topics - ~8-10 years: Owns CMC sections and regulatory strategy for Phase 3 program - 10+ years: Sets regulatory direction, leads HA negotiations, accountable for CMC approval risk - Strong communication skills in English - Passion for Drug Development (small molecules) **What's on Offer** The selected candidate will be part of a dynamic team in an international environment and actively contribute to shape, develop, and drive the market authorization of innovative drugs. Hybrid work model. Extension or take-over possibility. **Contact: Kamila Fotiou** **Quote job ref: JN-122025-6909033** Quelle: https://ch.linkedin.com/jobs/view/regulatory-affairs-cmc-d-f-m-at-michael-page-4345610298

Level: mid level