Offerta di lavoro Regulatory Affairs - CMC (d/f/m) a Zürich presso Michael Page.
Candidati su JOBSinITALY.it (riferimento #29980) per questa posizione a Zürich, Schweiz.
- 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**
Länk för att ansöka:
https://michaelpage.ch/job-apply/regulatory-affairs-cmc-dfm/ref/jn-122025-6909033?utm_campaign=onlineadverts&utm_medium=jobboard&utm_source=linkedin
