Director, Regulatory Affairs

Praxis Precision Medicines, Inc.; United States; Remote; USD 190,000 - 225,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Director of Regulatory Affairs to manage global regulatory strategies and submissions for CNS therapies. Candidates should have over 10 years of experience in regulatory roles within the industry, with strong expertise in clinical trials and regulatory interactions. The position offers an annual salary of $190,000 - $225,000 USD along with a comprehensive benefits package.

Benefits

401(k) with company match

Comprehensive medical/dental/vision benefits

Generous PTO and holidays

Stock incentives

Discretionary bonus

Qualifications

• 10+ years of experience in Regulatory Affairs within biotech/pharma.
• Direct experience in global clinical trials and regulatory submissions.
• Experience in antisense oligonucleotide or RNA-based therapeutics preferred.

Responsibilities

• Develop and lead global regulatory strategies.
• Oversee regulatory activities in global clinical trials.
• Manage regulatory submissions including INDs, NDAs, and MAAs.

Skills

Regulatory strategy development

Experience with IND/CTA and NDA/MAA submissions

Excellent communication skills

Knowledge of global regulatory practices

Education

PhD, PharmD, or MS in life science

Job description

Overview

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 role is pivotal for a regulatory leader with a science-driven mindset and a track record in small molecule and RNA-based therapeutics. Prior experience with antisense oligonucleotide development programs is preferred. The role supports global clinical development and leads regulatory activities for marketing applications, including NDAs and MAAs.

Responsibilities

• Develop and lead global regulatory strategies for 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 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

• Advanced degree (PhD, PharmD, or MS preferred) in a life science or regulatory-related field.
• 10+ years of experience in Regulatory Affairs within the biotech/pharma industry, with emphasis on clinical-stage programs.
• Direct experience in global clinical trials and regulatory submissions across multiple regions (US, EU, UK); experience in LATAM, Japan, and China is preferred.
• Demonstrated success with IND/CTA and NDA/MAA submissions, agency interactions, and clinical development in rare or neurological diseases across all development stages.
• 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’ collaborative, solution-oriented mindset and the ability to work with urgency, innovation, and integrity.

Compensation and Benefits

Annualized base salary: $190,000 - $225,000 USD. Large and comprehensive benefits package including medical/dental/vision, life insurance, disability benefits, 401(k) with company match, stock incentives, ESPP, discretionary bonus, flexible wellness benefits, generous PTO, and holidays.

Company Overview

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into therapies for central nervous system disorders. Our core values are Trust, Ownership, Curiosity, and Results. We are committed to diversity, equity and inclusion and are an equal opportunity employer.