Zurück zur Suche

Regulatory Affairs - CMC (d/f/m)

Basel-Region 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.

Aktualisiert am 10/01/2026

  • 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 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.

Stellenbeschreibung

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

Anforderungsprofil

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)

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-122025-6909033

Zusammenfassung

Berufsfeld
Healthcare & Life Sciences
Näheres Berufsfeld
Regulatory Affairs
Branche
Healthcare / Pharmaceutical
Ort
Basel-Region
Vertragsart
Interim
Referenznummer
JN-122025-6909033

Die PageGroup verpflichtet sich zu Chancengleichheit, als Arbeitgeber genauso wie als Dienstleistungsunternehmen. Wir treffen Rekrutierungsentscheidungen ausschließlich basierend auf Erfahrungen und Fähigkeiten der Bewerberinnen und Bewerber. Diese Maxime gilt nicht nur für unsere Mitarbeiterinnen und Mitarbeiter, sondern auch für unsere Arbeit in der Recruiting-Branche.