Senior Director, CMC Regulatory Affairs
About The Position
The Senior Director, Regulatory CMC will provide strategic and operational leadership for CMC regulatory activities across both investigational and commercial products at Praxis Precision Medicines, including small molecule and antisense oligonucleotide (ASO) programs. This role is responsible for developing and executing global CMC regulatory strategies to support clinical development, regulatory approvals, and ongoing lifecycle management, ensuring compliance with FDA and international regulatory requirements. The ideal candidate is a seasoned regulatory leader with deep CMC expertise across multiple therapeutic modalities and experience supporting products from early development through commercialization and post-approval.
Requirements
- Advanced degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline (PhD preferred; MS or equivalent with significant relevant experience considered).
- 10+ years of Regulatory Affairs experience with deep understanding of global CMC regulatory requirements across the full product lifecycle.
- Demonstrated experience supporting both investigational and commercial products, including small molecule and antisense oligonucleotide (ASO) therapeutics.
- Proven track record of authoring and/or overseeing CMC sections of INDs and NDAs, as well as post-approval supplements.
- Direct experience interacting with FDA and other global regulatory authorities on CMC-related matters.
- Strong strategic and operational leadership skills, with the ability to balance investigational and commercial priorities.
- Excellent written and verbal communication skills.
- Ability to work effectively in a fast-paced, cross-functional environment.
Nice To Haves
- Experience in biotech or pharmaceutical development; CNS, rare disease, or precision medicine experience is a plus.
- Prior people management and/or matrix leadership experience preferred.
Responsibilities
- Develop and lead global Regulatory CMC strategies for investigational and commercial small molecule and ASO products, aligned with development, manufacturing, and commercialization objectives.
- Serve as the Regulatory CMC subject matter expert, providing strategic guidance on regulatory risks, timelines, and mitigation plans across the product lifecycle.
- Ensure strong cross-functional partnership and alignment with Quality, Analytical, Development, Supply Chain and Commercial Manufacturing teams to support integrated CMC planning and execution.
- Author and oversee preparation, review, and submission of CMC sections for INDs, IMPDs, NDAs, and post-approval supplements, ensuring consistency, quality, and regulatory compliance.
- Lead and support CMC-related interactions with global health authorities (e.g., FDA, EMA), including meeting strategy, briefing materials, and responses to regulatory inquiries.
- Provide regulatory oversight for clinical and commercial manufacturing, including process validation, control strategies, stability programs, and supply continuity.
- Lead CMC regulatory strategies for post-approval changes, comparability assessments, technology transfers, and manufacturing site changes.
- Build and manage internal Regulatory CMC capabilities and oversee external consultants, CMOs, and regulatory vendors, contributing to scalable processes and governance.
Benefits
- 99% of the premium paid for medical, dental and vision plans.
- company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage
- dollar-for-dollar match up to 6% on eligible 401(k) contributions
- long-term stock incentives and ESPP
- discretionary quarterly bonus
- extremely flexible wellness benefit
- generous PTO, paid holidays and company-wide shutdowns
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
Number of Employees
101-250 employees
