Sr Manager / AD, Regulatory Strategy
Praxis Precision Medicines, Inc.
2 months ago
Remote friendly (United States)
United States
Corporate Functions
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) 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 on clinical trial design, patient selection, and regulatory requirements to support lifecycle activities.
- Support planning for future marketing applications by aligning development programs with global registration requirements.
- Monitor and interpret evolving regulatory guidance and communicate potential impact.
- Contribute to regulatory intelligence and continuous improvement of regulatory processes.
Qualifications
- Advanced degree (PharmD, MS, or equivalent) in a life science or regulatory-related field preferred.
- 6–10 years of Regulatory Strategy experience within biotech/pharma, with significant experience supporting clinical-stage development programs.
- Demonstrated experience managing IND lifecycle activities (protocol amendments, new INDs, global CTA maintenance).
- Experience supporting health authority interactions and preparing regulatory briefing packages.
Preferred
- Experience in rare disease and/or neurological indications.
- Understanding of accelerated regulatory pathways (e.g., orphan designation, breakthrough therapy).
Skills/Success Factors
- Strong project management; ability to manage multiple concurrent regulatory activities.
- Excellent communication and collaboration; translate regulatory requirements into actionable plans.
- Collaborative, solution-oriented mindset; ability to work with urgency, innovation, and integrity.
Compensation & Benefits
- Annualized base salary: $160,000 USD – $180,000 USD.
- Benefits include 99% premium coverage for medical/dental/vision, company-paid life insurance/AD&D/disability, 401(k) match up to 6%, long-term stock incentives and ESPP, discretionary quarterly bonus, flexible wellness benefit, generous PTO, and paid holidays/company shutdowns.
- 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) 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 on clinical trial design, patient selection, and regulatory requirements to support lifecycle activities.
- Support planning for future marketing applications by aligning development programs with global registration requirements.
- Monitor and interpret evolving regulatory guidance and communicate potential impact.
- Contribute to regulatory intelligence and continuous improvement of regulatory processes.
Qualifications
- Advanced degree (PharmD, MS, or equivalent) in a life science or regulatory-related field preferred.
- 6–10 years of Regulatory Strategy experience within biotech/pharma, with significant experience supporting clinical-stage development programs.
- Demonstrated experience managing IND lifecycle activities (protocol amendments, new INDs, global CTA maintenance).
- Experience supporting health authority interactions and preparing regulatory briefing packages.
Preferred
- Experience in rare disease and/or neurological indications.
- Understanding of accelerated regulatory pathways (e.g., orphan designation, breakthrough therapy).
Skills/Success Factors
- Strong project management; ability to manage multiple concurrent regulatory activities.
- Excellent communication and collaboration; translate regulatory requirements into actionable plans.
- Collaborative, solution-oriented mindset; ability to work with urgency, innovation, and integrity.
Compensation & Benefits
- Annualized base salary: $160,000 USD – $180,000 USD.
- Benefits include 99% premium coverage for medical/dental/vision, company-paid life insurance/AD&D/disability, 401(k) match up to 6%, long-term stock incentives and ESPP, discretionary quarterly bonus, flexible wellness benefit, generous PTO, and paid holidays/company shutdowns.