Sr Manager / AD, Regulatory Strategy
About The Position
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.
Requirements
- 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.
- 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.
Nice To Haves
- Experience in rare disease and/or neurological indications strongly preferred.
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.
Benefits
- 99% of the premium paid for medical, dental and vision plans.
- company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage
- dollar-for-dollar up to 6% on eligible 401(k) contributions
- long-term stock incentives and ESPP
- discretionary quarterly bonus
- extremely flexible wellness benefit
- generous PTO
- paid holidays and company-wide shutdowns
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
