Director, Regulatory Affairs Strategy
Travere Therapeutics
June 24, 2026
Remote friendly (United States)
United States
Corporate Functions
Position Summary:
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 strategic guidance to cross-functional teams.
Responsibilities:
- Develop and lead global regulatory strategies for Phase 2/Phase 3 programs.
- Provide guidance on clinical development plans, pivotal trial design, statistical considerations, and registration pathways.
- Identify regulatory risks/opportunities and create mitigation strategies.
- Lead regulatory planning for major milestones (e.g., End-of-Phase 2, Scientific Advice, Breakthrough Therapy Designation, Fast Track, PRIME, Accelerated Approval, Priority Review, marketing applications).
- Lead global regulatory agency meeting preparation, coordination, and execution; develop briefing packages and responses; represent the company in meetings/negotiations.
- Oversee submission of global regulatory documents (INDs/IND amendments, CTAs, annual reports/DSURs, pediatric plans/orphan submissions, NDA/BLA/MAA and other marketing applications); review/approve key documents for compliance and consistency.
- Collaborate with Clinical, Medical, CMC, Nonclinical, and Commercial teams; lead label/commercialization regulatory planning; mentor regulatory staff.
- Monitor regulatory requirements/trends; assess impact of changes; ensure compliance.
Qualifications:
- Bachelor’s degree in scientific/related field required (equitable skills/experience considered).
- Advanced degree preferred (PhD, PharmD, MD, MS).
- 10+ years progressive regulatory affairs experience in pharma/biotech/life sciences.
- Significant experience leading Phase 2/Phase 3 regulatory strategy; success with FDA/major global health authorities.
- Experience supporting/leading NDA/BLA/MAA (or equivalent).
- Strong knowledge of global drug development and clinical trial regulations; therapeutic area experience (oncology, rare disease, immunology, neuroscience, metabolic) preferred.
Additional Skills/Requirements:
- Strong communication, negotiation, influencing; leadership and cross-functional collaboration.
- Ability to manage complex issues in fast-paced environment; detail-oriented and organized.
- Ability to work across global time zones; travel 10–15% (may include weekends).
- Essential in-person function with colleagues/onsite in San Diego; not 100% remote.
Benefits:
- Benefits include premium health, 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:
- Apply on an ongoing basis until a candidate is selected.
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 strategic guidance to cross-functional teams.
Responsibilities:
- Develop and lead global regulatory strategies for Phase 2/Phase 3 programs.
- Provide guidance on clinical development plans, pivotal trial design, statistical considerations, and registration pathways.
- Identify regulatory risks/opportunities and create mitigation strategies.
- Lead regulatory planning for major milestones (e.g., End-of-Phase 2, Scientific Advice, Breakthrough Therapy Designation, Fast Track, PRIME, Accelerated Approval, Priority Review, marketing applications).
- Lead global regulatory agency meeting preparation, coordination, and execution; develop briefing packages and responses; represent the company in meetings/negotiations.
- Oversee submission of global regulatory documents (INDs/IND amendments, CTAs, annual reports/DSURs, pediatric plans/orphan submissions, NDA/BLA/MAA and other marketing applications); review/approve key documents for compliance and consistency.
- Collaborate with Clinical, Medical, CMC, Nonclinical, and Commercial teams; lead label/commercialization regulatory planning; mentor regulatory staff.
- Monitor regulatory requirements/trends; assess impact of changes; ensure compliance.
Qualifications:
- Bachelor’s degree in scientific/related field required (equitable skills/experience considered).
- Advanced degree preferred (PhD, PharmD, MD, MS).
- 10+ years progressive regulatory affairs experience in pharma/biotech/life sciences.
- Significant experience leading Phase 2/Phase 3 regulatory strategy; success with FDA/major global health authorities.
- Experience supporting/leading NDA/BLA/MAA (or equivalent).
- Strong knowledge of global drug development and clinical trial regulations; therapeutic area experience (oncology, rare disease, immunology, neuroscience, metabolic) preferred.
Additional Skills/Requirements:
- Strong communication, negotiation, influencing; leadership and cross-functional collaboration.
- Ability to manage complex issues in fast-paced environment; detail-oriented and organized.
- Ability to work across global time zones; travel 10–15% (may include weekends).
- Essential in-person function with colleagues/onsite in San Diego; not 100% remote.
Benefits:
- Benefits include premium health, 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:
- Apply on an ongoing basis until a candidate is selected.