Director, Regulatory AffairsUnited States - Remote

Director, Regulatory Affairs

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

The Opportunity Praxis is seeking an experienced and strategic Director of Regulatory Affairs to lead global regulatory initiatives across our clinical development programs. This is a high-impact role for a regulatory leader with a passion for science-driven development and a strong track record in small molecule and RNA-based therapeutics. The ideal candidate brings a deep understanding of the regulatory landscape, thrives in a collaborative environment, and is inspired by Praxis's mission to translate genetic insights into meaningful treatments for patients. Prior experience with antisense oligonucleotide development programs is preferred. This role will be pivotal in supporting global clinical development and leading regulatory activities for marketing applications, including NDAs and MAAs.

Primary Responsibilities

• Develop and lead global regulatory strategies for programs across all phases of developmentfrom preclinical through registration.
• Oversee regulatory activities in global clinical trials, ensuring compliance with international regulations and alignment with development goals.
• Own and manage regulatory submissions, including INDs, CTAs, NDAs, MAAs, briefing packages, and regulatory incentive requests, in collaboration with internal teams and external partners.
• Serve as the lead regulatory contact with global health authorities (e.g., FDA, EMA, MHRA, ANVISA, PMDA), including preparation for and participation in regulatory interactions and agency meetings.
• Collaborate closely with Clinical Development, Nonclinical, CMC, and Translational Science teams to ensure aligned, cross-functional regulatory strategy.
• Interpret regulatory guidance and evolving policy to support innovation in trial design, patient selection, and data generation for CNS therapies.
• Lead the planning and execution of marketing authorization applications, including regulatory strategy, content planning, cross-functional coordination, and responses to health authority questions.
• Contribute to corporate strategy, due diligence activities, and regulatory intelligence efforts that shape Praxis's overall development approach.

Qualifications and Key Success Factors

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.

Annualized Base Salary

$190,000 - $215,000 USD

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. Attention : Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.