CMC Regulatory Affairs Manager

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

Zusammenfassung

Incyte Corporation in Waadt, Morges, seeks a Manager/Senior Manager, Regulatory Affairs, CMC to lead regulatory CMC submissions and strategy for development and marketed products, spanning small molecules and biologics, from early development through late-stage. The role collaborates with internal partners and external health authorities to ensure compliant, high-quality submissions.

The ideal candidate has a science degree, relevant CMC regulatory experience, and a strong ability to navigate

Qualifikationen

• Bachelor's degree required in a relevant field.
• Advanced degrees in scientific, Regulatory Affairs or related fields desirable.
• 1-3 years of regulatory affairs CMC experience for Manager; 4-6 years for Senior Manager.
• Experience with regulatory CMC aspects of large and small molecule drugs is beneficial.
• Familiarity with global clinical trial and marketing applications, eCTD submissions, and electronic document management systems advantageous.
• Strong knowledge of pharmaceutical drug development and CMC regulations governing biologics and small molecules.

Aufgaben

• Participates in outside professional development meetings to apply latest CMC thinking.
• Maintains knowledge of US and international guidance and proposed rules affecting CMC.
• Liaises with internal teams and health authorities; prepares meeting summaries for regulatory archives.
• Supports post-approval activities and provides timely responses to regulatory questions.
• Ensures submissions adhere to current regulatory standards and high quality.
• Reviews CMC data packages to support trials and marketing applications.
• Supports regulatory CMC strategy for small and large molecule programs.
• Ensures compliance with regulatory guidance and internal policies.

Kenntnisse

Regulatory CMC

Regulatory strategy

Clinical development

Cross-functional comms

Ausbildung

Bachelor's degree

Advanced degree desirable

Jobbeschreibung

Incyte Corporation in Waadt, Morges, seeks a Manager/Senior Manager, Regulatory Affairs, CMC to lead regulatory CMC submissions and strategy for development and marketed products, spanning small molecules and biologics, from early development through late-stage. The role collaborates with internal partners and external health authorities to ensure compliant, high-quality submissions.

The ideal candidate has a science degree, relevant CMC regulatory experience, and a strong ability to navigate