Senior Director, CMC Regulatory Affairs

Location:  This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

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. 

Primary 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.

Qualifications and Key Success Factors

• 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.
• Prior people management and/or matrix leadership experience preferred.
• 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.

The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement.  You'll need comfort with screen work, basic hand coordination, and focus.  Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive.  This includes 99% of the premium paid for medical, dental and vision plans.  We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future?  We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP.  We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns.  Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring.  We aim high, collaborate hard, and produce results.  Let’s achieve the impossible together! 

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below.  Final salary range may be modified commensurate with job level, education, and experience.

Company Overview 

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.  At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders.  Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion
Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE^® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

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