Associate Director, Regulatory CMC - US (Remote)

Praxis Precision Medicines, Inc.; Northern (KY); Hybrid; USD 175,000 - 200,000; Full time

Job summary

Praxis Precision Medicines, Inc. is seeking an Associate Director, Regulatory CMC to lead planning, preparation, and execution of regulatory activities for small molecule and ASO programs. You will coordinate with cross-functional teams and external vendors to support global submissions.

The role demands hands-on CMC regulatory expertise, ownership mindset, and strong collaboration to ensure regulatory-compliant, high-quality outcomes in a fast-paced biotech environment.

Qualifications

• Bachelor’s, Master’s, or Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or another relevant scientific discipline.
• 10+ years of progressively responsible experience in Regulatory CMC or equivalent.

Responsibilities

• Support development and execution of CMC regulatory strategies for small molecule and ASO programs.
• Author, compile, and review CMC sections of regulatory submissions (INDs, IMPDs, NDAs, BLAs, amendments).
• Coordinate CMC content development with Quality, Analytical, Development, and Manufacturing teams.
• Support health authority interactions including briefing documents and information requests.
• Maintain regulatory compliance for CMC activities supporting clinical and commercial supply.
• Assist with post-approval change management and manufacturing changes.
• Manage external consultants, CMOs, CROs, and regulatory vendors.

Skills

Regulatory CMC

FDA knowledge

Cross-functional leadership

Project management

Regulatory submissions

External partnerships

Regulatory strategy

Attention to detail

Communication

Education

Advanced degree in Chemistry/Pharmaceutical Sciences/ Chemical Engineering/ Biochemistry

Job description

Praxis Precision Medicines, Inc. is seeking an Associate Director, Regulatory CMC to lead planning, preparation, and execution of regulatory activities for small molecule and ASO programs. You will coordinate with cross-functional teams and external vendors to support global submissions.

The role demands hands-on CMC regulatory expertise, ownership mindset, and strong collaboration to ensure regulatory-compliant, high-quality outcomes in a fast-paced biotech environment.