Senior Manager/Associate Director, CMC Regulatory Affairs
Praxis Precision Medicines, Inc. (1 month ago)
About this role
The Senior Manager, Regulatory CMC is responsible for overseeing the planning, preparation, and execution of chemistry, manufacturing, and controls (CMC) regulatory activities for both investigational and commercial biotech products. The role involves collaboration with cross-functional teams and external vendors to support global regulatory submissions, health authority interactions, and lifecycle management, focusing on small molecules and antisense oligonucleotide programs.
Required Skills
- Regulatory Affairs
- CMC
- INDs
- NDAs
- BLAs
- Global Regulatory
- Chemistry
- Manufacturing
- Compliance
- Drug Development
Qualifications
- Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field
- 5+ years of Regulatory Affairs experience
About Praxis Precision Medicines, Inc.
praxismedicines.comPraxis Medicines is a biopharmaceutical company focused on discovering and developing precision therapies for central nervous system (CNS) disorders. The company advances a portfolio of targeted candidates and applies a novel methodology aimed at transforming how neurological therapies are discovered and developed. Branded "Dare for MORE™," Praxis emphasizes ambitious, precision-driven science to tackle unmet needs in neurology and make challenging treatments possible.
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