Remote Associate Director, CMC Regulatory Strategy

Praxis Precision Medicines, Inc.; United States; Remote; USD 175,000 - 200,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) match

Stock incentives

ESPP

Discretionary quarterly bonus

Generous PTO

Company-wide shutdowns

Job summary

Praxis Precision Medicines, Inc. is seeking an Associate Director, Regulatory CMC to lead planning, preparation, and execution of CMC regulatory activities for both investigational and commercial programs, including small molecules and ASOs.

The role collaborates with cross-functional teams and external vendors to support global submissions and health authority interactions in a fast-paced biotech environment.

Qualifications

• 10+ years of experience in Regulatory CMC or related field.
• Hands-on SME in one or more CMC disciplines.
• Experience preparing CMC content for INDs/NDAs/BLAs and post-approval submissions.
• Knowledge of FDA and global CMC regulatory requirements.
• Experience with ASOs or oligonucleotide therapies preferred.
• Strong leadership and cross-functional influence.

Responsibilities

• Support development and execution of CMC regulatory strategies.
• Author and review CMC sections for regulatory submissions.
• Coordinate CMC content with Quality, Analytical, Development, and Manufacturing.
• Support health authority interactions and information requests.
• Maintain regulatory compliance for CMC activities.
• Assist post-approval change management and tech transfers.
• Manage external consultants, CMOs, CROs, and vendors.

Skills

Regulatory CMC expertise

CMC submissions

Cross-functional leadership

Project management

AI tools for regulatory prep

Regulatory strategy

Education

PhD in Chemistry/Pharmaceutical Sciences

Advanced degree in related field

Job description

Praxis Precision Medicines, Inc. is seeking an Associate Director, Regulatory CMC to lead planning, preparation, and execution of CMC regulatory activities for both investigational and commercial programs, including small molecules and ASOs.

The role collaborates with cross-functional teams and external vendors to support global submissions and health authority interactions in a fast-paced biotech environment.