Associate Director, Regulatory CMC
Praxis Precision Medicines, Inc.
August 26, 2026
Remote friendly (Boston, MA)
United States
Corporate Functions
Position Summary
- Plan, prepare, and execute Chemistry, Manufacturing, and Controls (CMC) regulatory activities for investigational and commercial products (small molecule and antisense oligonucleotide [ASO] programs).
- Partner with cross-functional teams and external vendors to support global regulatory submissions, health authority interactions, and lifecycle management.
Primary Responsibilities
- Support development and execution of CMC regulatory strategies (under the direction of the Senior Director).
- Author, compile, and review CMC sections for INDs, IMPDs, NDAs, BLAs, amendments, and post-approval supplements.
- Coordinate CMC content with Quality, Analytical, Development, and Commercial Manufacturing.
- Support health authority interactions (briefing documents, information request responses).
- Maintain CMC regulatory compliance for clinical and commercial supply.
- Assist with post-approval change management, comparability, manufacturing changes, and technology transfers.
- Manage external consultants, CMOs, CROs, and regulatory vendors.
Qualifications & Key Success Factors
- BS/MS/Ph.D. in Chemistry/Pharmaceutical Sciences/Chemical Engineering/Biochemistry (or related); 10+ years progressively responsible Regulatory CMC and/or technical CMC (or equivalent).
- Hands-on subject matter expertise across one or more CMC disciplines; ability to interpret complex data and translate into regulatory strategy.
- Extensive experience preparing/reviewing/managing CMC content for IND/IMPD/NDA/BLA and post-approval submissions; strong FDA and global CMC regulatory knowledge.
- Small molecule experience; ASO/oligonucleotide therapy experience strongly preferred.
- Leadership in complex CMC regulatory activities, including health authority interactions; influence cross-functional teams and external partners.
- Ownership mindset; proactive, accountable, and delivery-focused.
- Strong project management and written/verbal communication; manage multiple programs in a fast-paced environment.
- Proficiency leveraging AI/digital tools for document preparation/review and analysis while maintaining scientific judgment, data integrity, confidentiality, and compliance.
Compensation & Benefits
- Annualized Base Salary: $175,000–$200,000 USD.
- Benefits include 99% premium paid for medical/dental/vision; company-paid life/AD&D/disability; 401(k) match up to 6%; long-term stock incentives and ESPP; discretionary quarterly bonus; flexible wellness benefit; generous PTO and paid holidays.
Location/Work Requirements
- May be performed remotely; flexibility to travel as needed.
- Plan, prepare, and execute Chemistry, Manufacturing, and Controls (CMC) regulatory activities for investigational and commercial products (small molecule and antisense oligonucleotide [ASO] programs).
- Partner with cross-functional teams and external vendors to support global regulatory submissions, health authority interactions, and lifecycle management.
Primary Responsibilities
- Support development and execution of CMC regulatory strategies (under the direction of the Senior Director).
- Author, compile, and review CMC sections for INDs, IMPDs, NDAs, BLAs, amendments, and post-approval supplements.
- Coordinate CMC content with Quality, Analytical, Development, and Commercial Manufacturing.
- Support health authority interactions (briefing documents, information request responses).
- Maintain CMC regulatory compliance for clinical and commercial supply.
- Assist with post-approval change management, comparability, manufacturing changes, and technology transfers.
- Manage external consultants, CMOs, CROs, and regulatory vendors.
Qualifications & Key Success Factors
- BS/MS/Ph.D. in Chemistry/Pharmaceutical Sciences/Chemical Engineering/Biochemistry (or related); 10+ years progressively responsible Regulatory CMC and/or technical CMC (or equivalent).
- Hands-on subject matter expertise across one or more CMC disciplines; ability to interpret complex data and translate into regulatory strategy.
- Extensive experience preparing/reviewing/managing CMC content for IND/IMPD/NDA/BLA and post-approval submissions; strong FDA and global CMC regulatory knowledge.
- Small molecule experience; ASO/oligonucleotide therapy experience strongly preferred.
- Leadership in complex CMC regulatory activities, including health authority interactions; influence cross-functional teams and external partners.
- Ownership mindset; proactive, accountable, and delivery-focused.
- Strong project management and written/verbal communication; manage multiple programs in a fast-paced environment.
- Proficiency leveraging AI/digital tools for document preparation/review and analysis while maintaining scientific judgment, data integrity, confidentiality, and compliance.
Compensation & Benefits
- Annualized Base Salary: $175,000–$200,000 USD.
- Benefits include 99% premium paid for medical/dental/vision; company-paid life/AD&D/disability; 401(k) match up to 6%; long-term stock incentives and ESPP; discretionary quarterly bonus; flexible wellness benefit; generous PTO and paid holidays.
Location/Work Requirements
- May be performed remotely; flexibility to travel as needed.