CMC Senior Specialist: Regulatory Submissions & Lifecycle

Sintetica; Mendrisio; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Sintetica, founded in 1921 and based in Mendrisio, Switzerland, seeks a CMC Senior Specialist to manage CMC activities for drug product registrations, lifecycle management, and regulatory compliance throughout the product lifecycle. You will prepare and maintain CMC documentation and serve as the focal point for regulatory interactions.

Reporting to the CMC Coordinator, you will collaborate across Pharmaceutical Development, Manufacturing, Quality, and Regulatory Affairs, and with external

Qualifikationen

• Bachelor’s or Master’s degree in Chemistry or Pharmaceutical Chemistry.
• 8–10 years in pharma with CMC, Regulatory Affairs, or related areas.
• Experience with sterile injectable products and aseptic processing.
• Proven ability to prepare CMC documentation (Modules 2.3 and 3).
• Strong knowledge of ICH, EU, US, Swiss regulatory submissions including process validation, stability and related studies.
• Experience with Change Control and lifecycle management.
• Excellent English technical writing and communication.
• Strong planning and prioritization to manage multiple deadlines.

Aufgaben

• Define CMC strategies for new products with emphasis on US FDA requirements.
• Compile and review data to prepare CMC modules 2.3 and 3 for registrations and lifecycle activities.
• Coordinate with internal teams and external partners for regulatory submissions.
• Review Change Controls affecting manufacturing, analytical and quality changes; advise on regulatory strategy.
• Support tech transfer and post-approval activities from a CMC perspective.
• Pursue ongoing learning through courses and meetings to improve know-how.

Kenntnisse

English proficiency

Technical writing

Planning and prioritization

Analytical thinking

Regulatory compliance

Cross-functional coordination

Ausbildung

Bachelor's or Master’s in Chemistry/Pharmaceutical Chemistry

Jobbeschreibung

Sintetica, founded in 1921 and based in Mendrisio, Switzerland, seeks a CMC Senior Specialist to manage CMC activities for drug product registrations, lifecycle management, and regulatory compliance throughout the product lifecycle. You will prepare and maintain CMC documentation and serve as the focal point for regulatory interactions.

Reporting to the CMC Coordinator, you will collaborate across Pharmaceutical Development, Manufacturing, Quality, and Regulatory Affairs, and with external