Director, Regulatory Affairs Strategy
Travere Therapeutics
June 24, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Corporate Functions
Position Summary:
The Director, Regulatory Affairs Strategy develops and executes global regulatory strategies for Phase 2 and Phase 3 programs to support clinical development, registration, and commercialization. Serves as regulatory lead for assigned programs and provides strategic guidance to cross-functional teams.
Responsibilities:
- Develop and lead global regulatory strategies for Phase 2/3 clinical development programs.
- 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 major milestones (e.g., End-of-Phase 2, Scientific Advice, Fast Track/PRIME, Breakthrough Therapy Designation, Accelerated Approval, Priority Review, marketing applications).
- Serve as regulatory representative on cross-functional program teams and governance committees.
Health Authority Interactions:
- Prepare, coordinate, and execute global regulatory agency meetings.
- Develop briefing documents, regulatory questions, meeting strategies, and response packages.
- Represent the company during agency meetings/negotiations.
- Align strategy across regions while addressing local requirements.
Regulatory Submissions:
- Oversee preparation/submission of INDs/IND amendments, CTAs, annual reports/DSURs, pediatric plans/orphan submissions, and NDA/BLA/MAA (and other marketing applications).
- Review/approve key submission documents.
Collaboration & Compliance:
- Partner with Clinical, Medical, CMC, Nonclinical, and Commercial teams; lead label development/commercialization planning.
- Monitor regulatory requirements/trends and advise leadership; ensure compliance with regulations and company procedures.
Qualifications:
- Bachelor’s in scientific/related field required; advanced degree preferred.
- 10+ years progressive regulatory affairs experience; significant Phase 2/3 regulatory strategy experience.
- Demonstrated success with FDA and other global health authorities.
- Experience supporting/leading NDA/BLA/MAA submissions; strong understanding of global drug development.
- Preferred therapeutic area experience: oncology, rare disease, immunology, neuroscience, or metabolic disease.
Additional requirements/skills:
- Courage, community spirit, patient focus, teamwork; strong communication/negotiation/influencing.
- Ability to manage complex regulatory issues in fast-paced environment; strong leadership, strategic thinking, problem-solving, and organizational skills.
- Ability to work across global time zones; travel 10–15% possible; onsite/face-to-face essential in San Diego; not 100% remote.
Benefits:
- Premium health, financial/work-life/well-being offerings, wellness/support programs, life insurance, disability, retirement with employer match, and generous paid time off.
- Target base pay range: $189,000.00–$246,000.00.
Application instructions:
- Applications accepted on an ongoing basis until a candidate is selected.
The Director, Regulatory Affairs Strategy develops and executes global regulatory strategies for Phase 2 and Phase 3 programs to support clinical development, registration, and commercialization. Serves as regulatory lead for assigned programs and provides strategic guidance to cross-functional teams.
Responsibilities:
- Develop and lead global regulatory strategies for Phase 2/3 clinical development programs.
- 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 major milestones (e.g., End-of-Phase 2, Scientific Advice, Fast Track/PRIME, Breakthrough Therapy Designation, Accelerated Approval, Priority Review, marketing applications).
- Serve as regulatory representative on cross-functional program teams and governance committees.
Health Authority Interactions:
- Prepare, coordinate, and execute global regulatory agency meetings.
- Develop briefing documents, regulatory questions, meeting strategies, and response packages.
- Represent the company during agency meetings/negotiations.
- Align strategy across regions while addressing local requirements.
Regulatory Submissions:
- Oversee preparation/submission of INDs/IND amendments, CTAs, annual reports/DSURs, pediatric plans/orphan submissions, and NDA/BLA/MAA (and other marketing applications).
- Review/approve key submission documents.
Collaboration & Compliance:
- Partner with Clinical, Medical, CMC, Nonclinical, and Commercial teams; lead label development/commercialization planning.
- Monitor regulatory requirements/trends and advise leadership; ensure compliance with regulations and company procedures.
Qualifications:
- Bachelor’s in scientific/related field required; advanced degree preferred.
- 10+ years progressive regulatory affairs experience; significant Phase 2/3 regulatory strategy experience.
- Demonstrated success with FDA and other global health authorities.
- Experience supporting/leading NDA/BLA/MAA submissions; strong understanding of global drug development.
- Preferred therapeutic area experience: oncology, rare disease, immunology, neuroscience, or metabolic disease.
Additional requirements/skills:
- Courage, community spirit, patient focus, teamwork; strong communication/negotiation/influencing.
- Ability to manage complex regulatory issues in fast-paced environment; strong leadership, strategic thinking, problem-solving, and organizational skills.
- Ability to work across global time zones; travel 10–15% possible; onsite/face-to-face essential in San Diego; not 100% remote.
Benefits:
- Premium health, financial/work-life/well-being offerings, wellness/support programs, life insurance, disability, retirement with employer match, and generous paid time off.
- Target base pay range: $189,000.00–$246,000.00.
Application instructions:
- Applications accepted on an ongoing basis until a candidate is selected.