Associate Director, Regulatory Affairs (ASO)

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.