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Associate Director, Regulatory CMC at Praxis Precision Medicines, Inc. - ApplyBlast

Associate Director, Regulatory CMC

Praxis Precision Medicines, Inc.

2 months ago

United States

Onsite

Full Time

Director

0 applicants

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About this role

The Associate Director, Regulatory CMC is responsible for planning, preparing, and executing Chemistry, Manufacturing, and Controls (CMC) regulatory activities for investigational and commercial products, including small molecules and antisense oligonucleotides. This role collaborates with cross‑functional teams and external vendors to support global regulatory submissions, health authority interactions, and lifecycle management, ensuring compliance and high‑quality outcomes.

Responsibilities

Develop and execute CMC regulatory strategies for investigational and commercial programs
Author, compile, and review CMC sections of INDs, IMPDs, NDAs, BLAs and post‑approval submissions
Manage external consultants, CMOs, CROs and coordinate cross‑functional teams

Skills

Qualifications

Bachelor's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry or related fieldMaster's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry or related fieldPh.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry or related field

About Praxis Precision Medicines, Inc.

praxismedicines.com

Headquarters

Boston, Massachusetts, United States

Company Size

51-200 employees

View Profile

Praxis Precision Medicines is a fully integrated, leading CNS precision neuroscience biopharmaceutical company that translates insights from genetic epilepsies into therapies for central nervous system disorders characterized by neuronal excitation-inhibition imbalance. The company advances a diversified pipeline across epilepsy and movement disorders using two proprietary platforms: Cerebrum™ (small molecules) and Solidus™ (antisense oligonucleotides). Guided by its DARE FOR MORE® philosophy, Praxis applies human genetics, translational science, and patient-guided development to deliver precision therapies for patients with complex brain disorders.