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Regulatory Affairs - CMC (d/f/m)

Basel-Country Interim View Job Description
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.

added 10/01/2026

  • 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 experienceinpharmaRegulatoryCMC 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.

Quote job ref
JN-122025-6909033

Job summary

Job Function
Healthcare & Life Sciences
Specialisation
Regulatory Affairs
Industry
Healthcare / Pharmaceutical
Location
Basel-Country
Contract Type
Interim
Job Reference
JN-122025-6909033

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