Associate Director, Regulatory CMC – Biotech & ASO Focus

Regulatory Jobs; United States; Remote; USD 175,000 - 200,000; Full time

Benefits offered by this job

Premium medical/dental/vision coverage

Company-paid life insurance

AD&D

Disability benefits

401(k) match

Stock incentives

ESPP

Quarterly bonus

Flexible wellness benefit

Generous PTO

Holidays and company-wide shutdowns

Job summary

Praxis Precision Medicines seeks an Associate Director, Regulatory CMC to lead planning, preparation, and execution of CMC regulatory activities for both investigational and commercial programs. The role collaborates with cross-functional teams and vendors to support global submissions, health authority interactions, and lifecycle management.

The ideal candidate has hands-on CMC expertise, ownership mindset, and can deliver scientifically sound regulatory outcomes in a fast-paced biotech

Qualifications

• Bachelor’s/Master’s/Ph.D. in a relevant science with 10+ years in Regulatory CMC or equivalent.
• Hands-on CMC SME with ability to interpret complex data and craft regulatory strategies.
• Experience preparing and managing CMC content for INDs, IMPDs, NDAs, BLAs, and post-approval submissions.
• Experience supporting small molecule and ASO programs; FDA and global CMC knowledge.
• Proven leadership of complex CMC activities and health authority interactions.

Responsibilities

• Develop and execute CMC regulatory strategies for INDs/NDAs/BLAs and post-approval changes.
• Author, compile, and review CMC sections across regulatory submissions.
• Coordinate content development with Quality, Analytical, Development, and Manufacturing teams.
• Support health authority interactions with briefing documents and information requests.
• Maintain regulatory compliance for CMC activities supporting clinical and commercial supply.
• Manage external consultants, CMOs, CROs, and regulatory vendors.
• Lead post-approval changes, comparability assessments, and tech transfers.

Skills

CMC regulatory

Regulatory leadership

Regulatory submissions

Cross-functional collaboration

Project management

AI tools in docs

Education

Advanced degree in Chemistry/Pharmaceutical Sciences

Tools

Regulatory databases

Job description

Praxis Precision Medicines seeks an Associate Director, Regulatory CMC to lead planning, preparation, and execution of CMC regulatory activities for both investigational and commercial programs. The role collaborates with cross-functional teams and vendors to support global submissions, health authority interactions, and lifecycle management.

The ideal candidate has hands-on CMC expertise, ownership mindset, and can deliver scientifically sound regulatory outcomes in a fast-paced biotech