Director, Regulatory Affairs Strategy
Travere Therapeutics
August 06, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Corporate Functions
Position Summary:
The Director, Regulatory Affairs Strategy is responsible for developing and executing global regulatory strategies for Phase 2 and Phase 3 development programs to support clinical development, registration, and commercialization. Serves as regulatory lead for assigned programs and strategic guidance to cross-functional teams to align global regulatory requirements with corporate objectives.
Responsibilities:
- Develop and lead global regulatory strategies for Phase 2 and Phase 3.
- Provide regulatory guidance on clinical development plans, pivotal trial design, statistical considerations, and registration pathways.
- Evaluate regulatory risks/opportunities and develop mitigation strategies.
- Lead regulatory planning for End-of-Phase 2, Scientific Advice, Breakthrough Therapy Designation, Fast Track, PRIME, Accelerated Approval, Priority Review, and marketing applications.
- Lead preparation/coordination/execution of global regulatory agency meetings; develop briefing documents and responses; represent the company in meetings and negotiations.
- Oversee preparation/submission of INDs and amendments, CTAs, annual reports/DSURs, pediatric plans/orphan submissions, and NDA/BLA/MAA/other marketing applications; review/approve key documents.
- Collaborate with Clinical, Medical, CMC, Nonclinical, and Commercial; provide leadership for label development and commercialization planning; mentor regulatory staff.
- Monitor regulatory requirements/trends; assess impacts of regulatory changes; ensure compliance.
Education/Experience Requirements:
- Bachelor’s degree in a scientific/related field required.
- Advanced degree preferred (PhD, PharmD, MD, MS).
- 10+ years progressive regulatory affairs experience; significant experience leading Phase 2/Phase 3 regulatory strategy.
- Demonstrated success with FDA and major global health authorities.
- Experience supporting/leading NDA/BLA/MAA (or equivalent) submissions.
- Strong understanding of global drug development/regulatory frameworks.
- Therapeutic area experience preferred (oncology, rare disease, immunology, neuroscience, metabolic disease).
Additional Skills/Requirements:
- Strong communication, negotiation, influencing, leadership, cross-functional collaboration.
- Ability to manage complex regulatory issues in fast-paced environments; detail-oriented.
- Work across global time zones; travel 10–15% (may include weekends).
- Onsite/face-to-face essential function in San Diego; not 100% remote.
Benefits:
- Benefits include premium health, financial, work-life/well-being, wellness/support programs, life insurance, disability, retirement with employer match, and generous paid time off.
- Target Base Pay Range: $189,000–$246,000.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected for the position.
The Director, Regulatory Affairs Strategy is responsible for developing and executing global regulatory strategies for Phase 2 and Phase 3 development programs to support clinical development, registration, and commercialization. Serves as regulatory lead for assigned programs and strategic guidance to cross-functional teams to align global regulatory requirements with corporate objectives.
Responsibilities:
- Develop and lead global regulatory strategies for Phase 2 and Phase 3.
- Provide regulatory guidance on clinical development plans, pivotal trial design, statistical considerations, and registration pathways.
- Evaluate regulatory risks/opportunities and develop mitigation strategies.
- Lead regulatory planning for End-of-Phase 2, Scientific Advice, Breakthrough Therapy Designation, Fast Track, PRIME, Accelerated Approval, Priority Review, and marketing applications.
- Lead preparation/coordination/execution of global regulatory agency meetings; develop briefing documents and responses; represent the company in meetings and negotiations.
- Oversee preparation/submission of INDs and amendments, CTAs, annual reports/DSURs, pediatric plans/orphan submissions, and NDA/BLA/MAA/other marketing applications; review/approve key documents.
- Collaborate with Clinical, Medical, CMC, Nonclinical, and Commercial; provide leadership for label development and commercialization planning; mentor regulatory staff.
- Monitor regulatory requirements/trends; assess impacts of regulatory changes; ensure compliance.
Education/Experience Requirements:
- Bachelor’s degree in a scientific/related field required.
- Advanced degree preferred (PhD, PharmD, MD, MS).
- 10+ years progressive regulatory affairs experience; significant experience leading Phase 2/Phase 3 regulatory strategy.
- Demonstrated success with FDA and major global health authorities.
- Experience supporting/leading NDA/BLA/MAA (or equivalent) submissions.
- Strong understanding of global drug development/regulatory frameworks.
- Therapeutic area experience preferred (oncology, rare disease, immunology, neuroscience, metabolic disease).
Additional Skills/Requirements:
- Strong communication, negotiation, influencing, leadership, cross-functional collaboration.
- Ability to manage complex regulatory issues in fast-paced environments; detail-oriented.
- Work across global time zones; travel 10–15% (may include weekends).
- Onsite/face-to-face essential function in San Diego; not 100% remote.
Benefits:
- Benefits include premium health, financial, work-life/well-being, wellness/support programs, life insurance, disability, retirement with employer match, and generous paid time off.
- Target Base Pay Range: $189,000–$246,000.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected for the position.