Europe CMC Regulatory Director – Oncology

headcount; Basel; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Headcount is seeking a Director of Regulatory Affairs CMC Europe to lead the regulatory strategy for novel small-molecule therapies in oncology. This role requires steering global CMC development, submissions and lifecycle management across clinical, regulatory and manufacturing functions, with a focus on Module 3 and interactions with FDA/EMA.

The candidate will collaborate across Development, Quality and Supply Chain to ensure timely, successful global submissions while shaping the strategy

Qualifikationen

• Significant experience in Regulatory Affairs CMC within pharmaceutical/biotech industry.
• Strong background in small molecules and ideally New Chemical Entities (NCEs).
• Experience developing and executing global CMC regulatory strategies from clinical development through registration and lifecycle management.
• Strong knowledge of Module 3, global CMC submissions and health authority interactions.
• Oncology experience is highly desirable.
• A collaborative leader who thrives in a fast-paced, science-driven biotech environment.

Aufgaben

• Lead the global CMC regulatory strategy for innovative small-molecule development programmes.
• Drive CMC activities across clinical development, registration and lifecycle management.
• Develop and oversee global CMC submission strategies, including Module 3.
• Lead interactions with global Health Authorities, including FDA and EMA.
• Partner closely with Technical Development, Quality, Manufacturing and Supply Chain to ensure successful global submissions.
• Assess regulatory risks and provide strategic guidance throughout product development.

Kenntnisse

Regulatory Affairs CMC

Small molecules

NCEs

Global submissions

Module 3

Health Authority interactions

Oncology experience

Jobbeschreibung

Headcount is seeking a Director of Regulatory Affairs CMC Europe to lead the regulatory strategy for novel small-molecule therapies in oncology. This role requires steering global CMC development, submissions and lifecycle management across clinical, regulatory and manufacturing functions, with a focus on Module 3 and interactions with FDA/EMA.

The candidate will collaborate across Development, Quality and Supply Chain to ensure timely, successful global submissions while shaping the strategy