Manager, Global Regulatory Affairs, CMC
HybridSchaffhausen, Schaffhausen, Switzerland or Allschwil, Basel-Landschaft, Switzerland
Job Summary
Lead global CMC regulatory activities for large molecules in clinical and post-marketing phases by developing submission plans and executing regulatory strategies aligned with scientific and risk-based principles. Participate as the Regulatory CMC Lead on cross-functional teams to represent regulatory expertise, develop global dossier content, and ensure compliance with EU and FDA requirements throughout the product lifecycle. Provide strategic guidance on Health Authority interactions, develop contingency plans for registration issues, and communicate critical regulatory matters to management while maintaining positive relationships with health authorities. This onsite/hybrid role requires a Principal Scientist with an MS, PhD, or Pharm.D. and 8+ years of experience in biologics and large molecule development, with up to 10% travel.
Required Qualifications
- A BS/BA in biological, pharmaceutical, chemical or engineering sciences
- Minimum of 8+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent
- Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry
- Experience in biologics
- Experience developing regulatory strategies
- An understanding of product development
- High-level verbal and written communication skills
- Strong attention to detail
- The ability to potentially travel up to 10% travel, domestic and/or international
Desired Qualifications
- An MS, Ph.D., or Pharm. D. degree
- Experience developing regulatory strategies and an understanding of product development
- Knowledge of EU and FDA regulations
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