Senior Director, CMC Regulatory Affairs

Praxis Precision Medicines, Inc. (1 month ago)

RemoteFull TimeSenior$260,000 - $283,000Regulatory Affairs

About this role

The Senior Director, Regulatory CMC at Praxis Precision Medicines is responsible for providing strategic and operational leadership for CMC regulatory activities across investigational and commercial products, including small molecules and antisense oligonucleotides. The role involves developing global regulatory strategies, supporting product lifecycle management, and ensuring compliance with regulatory requirements, supporting the company's drug development and commercialization efforts.

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Required Skills

CMC
Regulatory Strategy
IND
NDAs
FDA
Post-Approval
Global Regulatory
Process Validation
Regulatory Compliance
Life Cycle Management

Qualifications

PhD in Chemistry, Pharmaceutical Sciences, Chemical Engineering or related
10+ years of Regulatory Affairs experience
Experience with Investigational and Commercial products
Experience interacting with FDA and global regulators
Supporting small molecules and antisense oligonucleotides

About Praxis Precision Medicines, Inc.

praxismedicines.com

Praxis 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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