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Technical Regulatory Affairs (CMC)

Basel-Region Interim View Job Description
For our client, a globally renowned pharmaceutical company in the Basel area, we are seeking a Technical Regulatory Affairs CMC (Associate Director) to strengthen the team in 2026 in support of Phase 3 development activities. The contract duration is 12-24 months.Depending on the selected candidate's performance and motivation, the possibility of an extension or a permanent take over.

Aktualisiert am 26/01/2026

  • Globally operating pharmaceutical company
  • Temporary assignment for 12-24 months

Firmenprofil

For our client, a globally renowned pharmaceutical company in the Basel area, we are seeking a Technical Regulatory Affairs CMC (Associate Director) to strengthen the team in 2026 in support of Phase 3 development activities. The contract duration is 12-24 months.

Depending on the selected candidate's performance and motivation, the possibility of an extension or a permanent take over.

Stellenbeschreibung

You will drive technical/CMC regulatory strategies for global development and registration, ensuring alignment with health authorities and leading documentation across the entire product lifecycle.

  • Designing and leading Technical Regulatory Affairs strategy for assigned projects
  • Preparing regulatory quality documents (CTD Modules 2 & 3, IMPD, IND)
  • Preparing briefing books for Health Authority meetings
  • Coordinating with CMC, DRA, QPs, CMOs, and regulatory partners
  • Leading cross-functional discussions and resolving documentation challenges
  • Evaluating regulatory impact of product and process changes
  • Ensuring global regulatory and GMP compliance
  • Managing documentation storage and tracking global submissions

Anforderungsprofil

To be successful in this role, you should bring:

  • Master's degree or higher in a scientific field.
  • 7+ years experience in technical/CMC regulatory affairs.
  • Strong knowledge of ICH, GMP and global regulatory procedures.
  • Understanding of drug substance/product development and manufacturing.
  • Excellent communication, leadership and organizational skills.
  • Fluent English; additional European languages beneficial.
  • Proficient in MS Office and documentation systems.

Sonstige Informationen

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.

Referenznummer angeben
JN-012026-6931099

Zusammenfassung

Berufsfeld
Healthcare & Life Sciences
Näheres Berufsfeld
Regulatory Affairs
Branche
Healthcare / Pharmaceutical
Ort
Basel-Region
Vertragsart
Interim
Referenznummer
JN-012026-6931099

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