Manager, Regulatory Affairs Strategy
Travere Therapeutics
August 29, 2026
On-site
San Diego Metropolitan Area
Corporate Functions
Position Summary:
Manager, Regulatory Affairs provides regulatory leadership and execution support for late-stage development programs, global regulatory strategy implementation (development through registration and lifecycle management), regulatory planning/submission execution, Health Authority interactions, and preparation for major regulatory milestones.
Responsibilities:
- Support global regulatory strategies for late-stage development and registration.
- Represent Regulatory Affairs on cross-functional project teams and provide regulatory input.
- Coordinate preparation/submission of INDs, CTAs, amendments, annual reports, briefing packages, and marketing components (NDA/BLA/MAA).
- Lead regulatory document preparation; collaborate with SMEs for dossier readiness.
- Support Health Authority interactions (meeting requests, briefing docs, responses, post-meeting commitments).
- Partner with Clinical, Nonclinical, CMC, Regulatory Operations, Medical Writing, and Project Management for registration planning/execution.
- Plan/manage tracking of regulatory submission content and timelines.
- Support lifecycle management (post-approval commitments, variations, supplements, labeling updates).
- Identify regulatory risks and develop mitigation strategies.
- Manage regulatory consultants, contract resources, and vendors as needed.
- Evaluate emerging regulations/guidance for regulatory intelligence.
- Contribute to regulatory process/template/best-practice improvement.
Education/Experience Requirements:
- Bachelor’s in Life Sciences (or related); equivalent combination considered.
- Advanced degree preferred.
- 6+ years regulatory affairs in pharma/biotech.
- Experience with clinical-stage development and global regulatory submissions.
- Working knowledge of FDA, EMA, ICH, and other global requirements; IND/CTA experience.
- Strong late-stage drug development/regulatory knowledge; Phase 3/lifecycle experience.
Additional Skills/Requirements (Preferred/Required):
- Values-driven; patient-focused.
- Knowledge of FDA/EMA/MHRA/PMDA/Health Canada/ICH and global CMC requirements.
- Strong PM/organizational skills; excellent written/verbal communication.
- Independent yet collaborative; sound regulatory judgment.
- Ability to travel up to 10%.
- Must be able to perform face-to-face/onsite in San Diego; not 100% remote.
Benefits (as stated):
Premium health and financial/well-being offerings, wellness/support programs, life insurance, disability, retirement match, and generous paid time off.
Compensation:
Target base pay range: $116,000–$151,000.
Application Instructions:
- Applications accepted on an ongoing basis until the role is filled.
Manager, Regulatory Affairs provides regulatory leadership and execution support for late-stage development programs, global regulatory strategy implementation (development through registration and lifecycle management), regulatory planning/submission execution, Health Authority interactions, and preparation for major regulatory milestones.
Responsibilities:
- Support global regulatory strategies for late-stage development and registration.
- Represent Regulatory Affairs on cross-functional project teams and provide regulatory input.
- Coordinate preparation/submission of INDs, CTAs, amendments, annual reports, briefing packages, and marketing components (NDA/BLA/MAA).
- Lead regulatory document preparation; collaborate with SMEs for dossier readiness.
- Support Health Authority interactions (meeting requests, briefing docs, responses, post-meeting commitments).
- Partner with Clinical, Nonclinical, CMC, Regulatory Operations, Medical Writing, and Project Management for registration planning/execution.
- Plan/manage tracking of regulatory submission content and timelines.
- Support lifecycle management (post-approval commitments, variations, supplements, labeling updates).
- Identify regulatory risks and develop mitigation strategies.
- Manage regulatory consultants, contract resources, and vendors as needed.
- Evaluate emerging regulations/guidance for regulatory intelligence.
- Contribute to regulatory process/template/best-practice improvement.
Education/Experience Requirements:
- Bachelor’s in Life Sciences (or related); equivalent combination considered.
- Advanced degree preferred.
- 6+ years regulatory affairs in pharma/biotech.
- Experience with clinical-stage development and global regulatory submissions.
- Working knowledge of FDA, EMA, ICH, and other global requirements; IND/CTA experience.
- Strong late-stage drug development/regulatory knowledge; Phase 3/lifecycle experience.
Additional Skills/Requirements (Preferred/Required):
- Values-driven; patient-focused.
- Knowledge of FDA/EMA/MHRA/PMDA/Health Canada/ICH and global CMC requirements.
- Strong PM/organizational skills; excellent written/verbal communication.
- Independent yet collaborative; sound regulatory judgment.
- Ability to travel up to 10%.
- Must be able to perform face-to-face/onsite in San Diego; not 100% remote.
Benefits (as stated):
Premium health and financial/well-being offerings, wellness/support programs, life insurance, disability, retirement match, and generous paid time off.
Compensation:
Target base pay range: $116,000–$151,000.
Application Instructions:
- Applications accepted on an ongoing basis until the role is filled.