Associate Director, Regulatory CMC

The role

The Associate Director, Regulatory CMC will plan, prepare, and execute CMC regulatory activities for investigational and commercial small molecule and antisense oligonucleotide programs. This role involves supporting global regulatory submissions, health authority interactions, and lifecycle management.

What you will do

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

Required 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 and/or technical CMC, or an equivalent combination of advanced education and experience
• Technical CMC expertise as a subject matter expert in one or more CMC disciplines
• Hands-on experience preparing, reviewing, and/or managing CMC content for INDs, IMPDs, NDAs, BLAs, and post-approval submissions
• Knowledge of FDA and global CMC regulatory requirements across development and commercial stages
• Leadership of complex CMC regulatory activities and health authority interactions
• Strong project management, organizational, written, and verbal communication skills
• Proficiency in leveraging AI tools and other digital technologies

Nice to have

• experience with antisense oligonucleotides (ASOs) or other oligonucleotide-based therapies

Benefits

• 99% of the premium paid for medical, dental and vision plans
• Company-paid life insurance
• AD&D
• Disability benefits
• Voluntary plans to personalize coverage
• Dollar-for-dollar 401(k) match up to 6%
• Long-term stock incentives
• ESPP
• Discretionary quarterly bonus
• Flexible wellness benefit
• Generous PTO
• Paid holidays and company-wide shutdowns

About the company

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders. The company focuses on developing high impact medicines for patients and families affected by complex brain disorders.