Sr Manager / AD, Regulatory Strategy

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.