Associate Director, Project Manager - Regulatory Affairs
Travere Therapeutics
August 21, 2026
Remote friendly (United States)
United States
Corporate Functions
Position Summary:
Associate Director, Regulatory Project Manager (RPM) leads and coordinates global regulatory affairs activities to ensure compliance with health authority requirements and to support regulatory submissions for investigational and commercial rare disease therapies.
Responsibilities:
- Lead regulatory project management for global development programs (plans, timelines, deliverables, submissions).
- Run Global Regulatory Team meeting operations (agenda, decisions, documentation, follow-up).
- Build and manage integrated regulatory project timelines across the product lifecycle.
- Plan and track regulatory submissions/maintenance (INDs, NDAs, BLAs, supplements, annual reports, DSURs, post-marketing commitments, responses).
- Collaborate cross-functionally (Regulatory Ops, Clinical Dev/Ops, CMC, Biostatistics, Medical Writing, Quality, Commercial, vendors).
- Coordinate submission readiness (content planning, ownership, review cycles, Vault RIM activities).
- Create dashboards/status reports; track risks, constraints, dependencies.
- Support health authority interactions/inspections/audits; drive process/tool/template improvements.
- Manage regulatory documentation and mentor team members.
Education/Experience Requirements:
- Bachelor’s in Life Sciences or related field required; MS/PharmD/PhD preferred.
- 8+ years project management in biotech/pharma; regulatory PM experience preferred.
- PMP strongly preferred.
- Timeline software expertise (e.g., Smartsheet, MS Project).
Additional Skills/Experience:
- Strong global regulatory affairs and compliance understanding; excellent organization, multitasking, risk management, communication, and stakeholder coordination.
- Ability to manage complex plans/critical paths; adapt to changes.
- Travel <10%; onsite/face-to-face in San Diego required (not 100% remote).
Benefits (as stated): premium health/financial/well-being offerings, wellness programs, life insurance, disability, retirement match, paid time off.
Application Instructions:
- Applications accepted on an ongoing basis until selected.
Associate Director, Regulatory Project Manager (RPM) leads and coordinates global regulatory affairs activities to ensure compliance with health authority requirements and to support regulatory submissions for investigational and commercial rare disease therapies.
Responsibilities:
- Lead regulatory project management for global development programs (plans, timelines, deliverables, submissions).
- Run Global Regulatory Team meeting operations (agenda, decisions, documentation, follow-up).
- Build and manage integrated regulatory project timelines across the product lifecycle.
- Plan and track regulatory submissions/maintenance (INDs, NDAs, BLAs, supplements, annual reports, DSURs, post-marketing commitments, responses).
- Collaborate cross-functionally (Regulatory Ops, Clinical Dev/Ops, CMC, Biostatistics, Medical Writing, Quality, Commercial, vendors).
- Coordinate submission readiness (content planning, ownership, review cycles, Vault RIM activities).
- Create dashboards/status reports; track risks, constraints, dependencies.
- Support health authority interactions/inspections/audits; drive process/tool/template improvements.
- Manage regulatory documentation and mentor team members.
Education/Experience Requirements:
- Bachelor’s in Life Sciences or related field required; MS/PharmD/PhD preferred.
- 8+ years project management in biotech/pharma; regulatory PM experience preferred.
- PMP strongly preferred.
- Timeline software expertise (e.g., Smartsheet, MS Project).
Additional Skills/Experience:
- Strong global regulatory affairs and compliance understanding; excellent organization, multitasking, risk management, communication, and stakeholder coordination.
- Ability to manage complex plans/critical paths; adapt to changes.
- Travel <10%; onsite/face-to-face in San Diego required (not 100% remote).
Benefits (as stated): premium health/financial/well-being offerings, wellness programs, life insurance, disability, retirement match, paid time off.
Application Instructions:
- Applications accepted on an ongoing basis until selected.