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 in pharma Regulatory CMC 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.
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