Manager/Sr Manager, Global Regulatory CMC (Pharmaceuticals)
About The Position
This position is in the Global Regulatory CMC group and is focused on the development and execution of global regulatory CMC strategies. There is a focus on early and late phase pharmaceutical and life-cycle management activities for small molecules/pharmaceuticals, antisense oligonucleotides (ASO) and innovative regulatory CMC approaches: Lead the development, implementation, and influence of CMC regulatory strategy Identify and assess global regulatory risks Develop global agency meeting strategies Serve as the global regulatory representative on relevant project teams Act as the primary global regulatory contact with relevant regulatory authorities Coordinate all CMC aspects of global regulatory submissions.
Requirements
- A minimum of 5-10 years strategic global regulatory CMC, or relevant regulatory experience.
- Demonstrate excellent communication and influencing skills internally and externally at all levels of the organization.
- Strong interperso
Responsibilities
- Lead the development, implementation, and influence of CMC regulatory strategy
- Identify and assess global regulatory risks
- Develop global agency meeting strategies
- Serve as the global regulatory representative on relevant project teams
- Act as the primary global regulatory contact with relevant regulatory authorities
- Coordinate all CMC aspects of global regulatory submissions
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
No Education Listed
Number of Employees
1,001-5,000 employees
