Principal Scientist (Director), Regulatory Affairs-CMC
MSD(25 days ago)
About this role
Principal Scientist, CMC (Pharm Pre-approval) is responsible for developing and implementing global CMC regulatory strategies for the company’s pharmaceutical pipeline with a focus on small-molecule respiratory/inhalation products. The role provides leadership and oversight of multiple programs in the Respiratory franchise, supports regulatory submissions (IND/CTA, marketing applications), and interfaces with senior leadership and external health authorities. The position is pre-approval focused and contributes to organizational regulatory readiness and strategy.
Required Skills
- Audits
- Compliance
- CMC Development
- Data Integrity
- Documentation
- DPI
- Inhalers
- Employee Training
- Organizational Optimization
- Process Development
+6 more
Qualifications
- Master's Degree in Chemistry or Pharmacy
- Postgraduate Degree Preferred
About MSD
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