Director, Regulatory Affairs

Praxis Precision Medicines, Inc.; United States; On-site; USD 165,000 - 193,000; Full time

Job summary

Praxis Precision Medicines, a pioneering biopharmaceutical company, seeks an Associate Director of Regulatory Affairs. This pivotal role involves leading regulatory strategies for antisense oligonucleotide programs and ensuring compliance across phases of clinical development. Join a collaborative team dedicated to delivering innovative treatments for central nervous system disorders.

Benefits

99% premium paid for health plans

401(k) match up to 6%

Discretionary bonus

Flexible wellness benefits

Generous PTO

Qualifications

• PhD, PharmD, or MS in a life science or regulatory-related field preferred.
• 8+ years in Regulatory Affairs within biotech/pharma.
• Experience with IND/CTA and NDA/MAA submissions.

Responsibilities

• Develop and lead global regulatory strategies for ASO-based programs.
• Oversee regulatory activities in global clinical trials.
• Own and manage regulatory submissions and interactions with global health authorities.

Skills

Regulatory strategy

Clinical trials

Agency interaction

Collaboration

Communication

Education

PhD in Life Sciences

MS in Regulatory Affairs

Job description

Join to apply for the Associate Director, Regulatory Affairs role at Praxis Precision Medicines, Inc.

Join to apply for the Associate Director, Regulatory Affairs role at Praxis Precision Medicines, Inc.

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 Associate Director of Regulatory Affairs to lead global regulatory initiatives across our antisense oligonucleotide (ASO) clinical development programs. This is a high-impact role for a regulatory professional with a passion for science-driven development and a strong track record in 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. 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 ASO-based programs across all phases of development—from 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 ASO 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

• Advanced degree (PhD, PharmD, or MS preferred) in a life science or regulatory-related field.
• 8+ years of experience in Regulatory Affairs within the biotech/pharma industry, with a strong emphasis on clinical-stage programs.
• Direct experience in global clinical trials and regulatory submissions across multiple regions (e.g., US, EU, UK). Experience in other regions (LATAM, Japan, China) also strongly preferred.
• Demonstrated success with IND/CTA and NDA/MAA submissions, regulatory agency interactions, and clinical development in rare or neurological diseases covering all stages of development from discovery through commercialization.
• Experience with antisense oligonucleotide or RNA-based therapeutics is strongly preferred.
• Familiarity with accelerated pathways, including orphan drug designation, rare pediatric disease designation, and breakthrough therapy designation.
• Excellent communication skills with the ability to represent regulatory strategy to internal teams, leadership, and external stakeholders.
• Aligned with Praxis’ ways of working – including a collaborative, solution-oriented mindset and the ability to work with urgency, innovation, and integrity.
• 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.

Annualized Base Salary: $165,000 USD - $193,000 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 [e-mail].

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.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

• Industries

  Biotechnology Research and Pharmaceutical Manufacturing

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