Regulatory CMC Lead — Global Submissions & Strategy

Incyte; Morges; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Zusammenfassung

Incyte in Switzerland seeks an experienced Manager/Senior Manager, Regulatory Affairs, CMC to lead regulatory CMC submissions and strategy for development and marketed products, from early development through post‑approval.

You will integrate with clinical, quality, and marketing teams, manage global submissions (eCTD) and health authority interactions, and ensure compliance with evolving regulations while mentoring junior staff.

Qualifikationen

• Bachelor's degree in a relevant field; advanced degrees desirable.
• 1-3 years experience for Manager, 4-6 years for Senior Manager in regulatory CMC.
• Experience with regulatory CMC for large and small molecules beneficial.

Aufgaben

• Participates in external meetings to apply latest CMC thinking.
• Maintains knowledge of US and international CMC guidelines and rules.
• Communicates regulatory CMC guidance to internal/external partners; liaises with health authorities as needed.
• Supports post-approval global product activities and provides timely responses to CMC regulatory questions.

Kenntnisse

Regulatory Affairs

CMC

eCTD submissions

Cross-functional leadership

Global health authorities

Ausbildung

Bachelor's degree in a relevant field

Advanced degree in Regulatory Affairs or related pharmaceutical fields

Tools

eCTD software

Jobbeschreibung

Incyte in Switzerland seeks an experienced Manager/Senior Manager, Regulatory Affairs, CMC to lead regulatory CMC submissions and strategy for development and marketed products, from early development through post‑approval.

You will integrate with clinical, quality, and marketing teams, manage global submissions (eCTD) and health authority interactions, and ensure compliance with evolving regulations while mentoring junior staff.