Sr Manager / AD, Regulatory Strategy at Praxis Precision Medicines, Inc.

United States

$160k - $180k

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 Senior Manager/Associate Director of Regulatory Strategy to support global regulatory initiatives and lifecycle management activities across our clinical development programs. You’ll play a key role in supporting regulatory strategies for ongoing clinical programs, including new INDs, protocol amendments, health authority interactions, and global lifecycle planning. This role is ideally suited for a regulatory professional with strong experience in managing and expanding existing INDs and advancing programs through mid- to late-stage development. The ideal candidate brings experience in small molecule and/or RNA-based therapeutics, strong operational execution skills, and the ability to work cross-functionally to ensure regulatory strategies align with evolving development plans. This role will be pivotal in supporting global clinical development and regulatory activities for INDs, CTAs, NDAs and MAAs. Primary Responsibilities Support the development and execution of global regulatory strategies for ongoing clinical-stage programs, with a strong focus on lifecycle management. Lead regulatory activities for clinical development programs, including new IND submissions, protocol amendments, annual reports, safety updates, and global CTA maintenance. Partner with Clinical Development, Nonclinical, CMC, and Translational teams to align regulatory strategy with evolving development objectives and timelines. Prepare and manage regulatory submissions (e.g., IND amendments, new INDs, CTAs, briefing packages) in collaboration with internal stakeholders and external vendors. Contribute to preparation for and participation in health authority interactions (e.g., FDA, EMA, MHRA), including meeting strategy, briefing document preparation, and response coordination. Provide regulatory guidance to cross-functional teams on clinical trial design, patient selection, and regulatory requirements to support lifecycle activities. Support planning for future marketing applications by ensuring development programs are conducted in alignment with global registration requirements. Monitor and interpret evolving regulatory guidance and communicate potential impact on ongoing programs. Contribute to regulatory intelligence efforts and continuous improvement of regulatory processes. Qualifications and Key Success Factors Advanced degree (PharmD, MS, or equivalent) in a life science or regulatory-related field preferred; six to ten years of experience in Regulatory Strategy within biotech/pharma, with significant experience supporting clinical-stage development programs. Demonstrated experience managing IND lifecycle activities, including protocol amendments, new INDs, and global CTA maintenance. Experience supporting health authority interactions and preparing regulatory briefing packages. Experience in rare disease and/or neurological indications strongly preferred. Understanding of accelerated regulatory pathways (e.g., orphan designation, breakthrough therapy) and their application to lifecycle strategy. Strong project management skills and ability to manage multiple concurrent regulatory activities. Excellent communication and collaboration skills, with the ability to translate regulatory requirements into actionable development plans. Aligned with Praxis’ ways of working – including a collaborative, solution-oriented mindset and the ability to work with urgency, innovation, and integrity. 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 $160,000—$180,000 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.