Praxis Precision Medicines, Inc. · 4 days ago
Senior Director, CMC Regulatory Affairs
United States
Full-time
Remote
Director/Executive
$260K/yr - $283K/yr
10+ years expPraxis Precision Medicines is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders. The Senior Director, Regulatory CMC will provide strategic and operational leadership for CMC regulatory activities, ensuring compliance with FDA and international regulatory requirements.
Alternative MedicineBiotechnologyHealth CareMedicalPrecision Medicine
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
Qualification
Required
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
Experience in biotech or pharmaceutical development; CNS, rare disease, or precision medicine experience is a plus
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
Preferred
Prior people management and/or matrix leadership experience preferred
Benefits
99% of the premium paid for medical, dental and vision plans
Company-paid life insurance
AD&D
Disability benefits
Voluntary plans to personalize your coverage
Match dollar-for-dollar up to 6% on eligible 401(k) contributions
Long-term stock incentives
ESPP
Discretionary quarterly bonus
Extremely flexible wellness benefit
Generous PTO
Paid holidays
Company-wide shutdowns
Company
Praxis Precision Medicines, Inc.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.67BKey Investors
Eventide
2026-01-06Post Ipo Equity· $575M
2025-10-16Post Ipo Equity· $525M
2024-03-28Post Ipo Equity· $200M
Leadership Team
Marcio Souza
President and CEO
Tim Kelly
Chief Financial Officer
Recent News
GlobeNewswire
2026-01-13
2026-01-11
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