Director, Regulatory Affairs

Role Summary

Director, Regulatory Affairs responsible for leading global regulatory initiatives across clinical development programs, with a focus on small molecule and RNA-based therapeutics. Provides strategic regulatory leadership for marketing applications including NDAs and MAAs, and serves as the primary regulatory contact with global health authorities.

Responsibilities

• Develop and lead global regulatory strategies for programs across all phases of development‚Äîfrom 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‚Äôs 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 a strong emphasis on clinical-stage programs.
• Direct experience in global clinical trials and regulatory submissions across multiple regions (US, EU, UK); experience in LATAM, Japan, China strongly preferred.
• Demonstrated success with IND/CTA and NDA/MAA submissions, regulatory agency interactions, and clinical development in rare or neurological diseases from discovery through commercialization.
• Experience with antisense oligonucleotide or RNA-based therapeutics 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.
• Collaborative, solution-oriented mindset with the ability to work with urgency, innovation, and integrity.

Skills

• Regulatory strategy development
• Global regulatory submissions (IND/CTA, NDA/MAA)
• Regulatory authority interactions and meetings
• Cross-functional collaboration
• Regulatory intelligence and policy interpretation
• Clinical development for CNS therapies

Education

• Advanced degree (PhD, PharmD, or MS preferred) in a life science or regulatory-related field.