Associate Director, Regulatory CMC
Praxis Precision Medicines, Inc.
September 02, 2026
Remote friendly (Boston, MA)
United States
Operations
Primary Responsibilities
- Support development and execution of CMC regulatory strategies for investigational and commercial small molecule and ASO programs (under the direction of the Senior Director).
- Author, compile, and review CMC sections of regulatory submissions (INDs, IMPDs, NDAs, BLAs, amendments, post-approval supplements).
- Coordinate CMC content development with Quality, Analytical, Development, and Commercial Manufacturing teams.
- Support health authority interactions (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.
Qualifications and Key Success Factors
- Bachelor’s, Master’s, or Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or related field; 10+ years progressively responsible Regulatory CMC and/or technical CMC experience.
- Hands-on CMC expertise as a subject matter expert; ability to interpret complex scientific/manufacturing data and translate into regulatory strategies.
- 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 therapies strongly preferred.
- Demonstrated leadership of complex CMC regulatory activities and cross-functional influence.
- Ownership mindset; proactive can-do attitude; accountable for outcomes.
- Strong project management and communication skills; manage multiple priorities in a fast-paced environment.
- Proficiency leveraging AI/digital tools while maintaining scientific judgment and data integrity.
Benefits / Compensation
- 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/ESPP; discretionary quarterly bonus; wellness benefit; generous PTO and paid holidays/company shutdowns.
- Support development and execution of CMC regulatory strategies for investigational and commercial small molecule and ASO programs (under the direction of the Senior Director).
- Author, compile, and review CMC sections of regulatory submissions (INDs, IMPDs, NDAs, BLAs, amendments, post-approval supplements).
- Coordinate CMC content development with Quality, Analytical, Development, and Commercial Manufacturing teams.
- Support health authority interactions (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.
Qualifications and Key Success Factors
- Bachelor’s, Master’s, or Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or related field; 10+ years progressively responsible Regulatory CMC and/or technical CMC experience.
- Hands-on CMC expertise as a subject matter expert; ability to interpret complex scientific/manufacturing data and translate into regulatory strategies.
- 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 therapies strongly preferred.
- Demonstrated leadership of complex CMC regulatory activities and cross-functional influence.
- Ownership mindset; proactive can-do attitude; accountable for outcomes.
- Strong project management and communication skills; manage multiple priorities in a fast-paced environment.
- Proficiency leveraging AI/digital tools while maintaining scientific judgment and data integrity.
Benefits / Compensation
- 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/ESPP; discretionary quarterly bonus; wellness benefit; generous PTO and paid holidays/company shutdowns.