Manager, Regulatory Affairs Strategy
Travere Therapeutics
August 08, 2026
Remote friendly (San Diego Metropolitan Area)
United States
Corporate Functions
Position Summary:
The Manager, Regulatory Affairs provides regulatory leadership and execution support for late-stage development programs and helps implement global regulatory strategies from development through registration and lifecycle management. Works with cross-functional teams to support regulatory planning, submission execution, Health Authority interactions, and preparation for major regulatory milestones.
Responsibilities:
- Support implementation of global regulatory strategies for late-stage development and registration activities.
- Represent Regulatory Affairs on cross-functional project teams and provide regulatory input on development, registration, and lifecycle management.
- Coordinate preparation and submission of regulatory applications (INDs, CTAs, amendments, annual reports, briefing packages, NDA/BLA/MAA components).
- Lead regulatory document preparation and collaborate with SMEs for submission milestones and dossier readiness.
- Support Health Authority interactions (meeting requests, briefing documents, responses, post-meeting commitments).
- Partner with Clinical, Nonclinical, CMC, Regulatory Operations, Medical Writing, and Project Management to plan and execute registrations.
- Support submission planning, content development, timeline management, and tracking of deliverables.
- Assist with lifecycle management (post-approval commitments, variations, supplements, labeling updates as applicable).
- Identify regulatory risks and develop mitigation strategies.
- Manage activities by regulatory consultants, contract resources, and external vendors.
- Evaluate emerging regulations/guidance/precedents; support process/template/best-practice improvements.
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences (or related) required; advanced degree preferred.
- 6+ years regulatory affairs experience in pharma/biotech.
- Experience with clinical-stage development and global submissions; working knowledge of FDA/EMA/ICH and other global requirements.
- Experience preparing/supporting IND/CTA submissions; strong understanding of late-stage drug development.
- Experience supporting Phase 3 and global post-approval lifecycle management.
Additional Skills/Requirements (Preferred/Required):
- Knowledge of FDA, EMA, MHRA, PMDA, Health Canada, ICH, and global CMC regulatory requirements.
- Health Authority interaction experience preferred.
- Strong project management/organizational skills; excellent communication.
- Ability to work independently with cross-functional teams; sound regulatory judgment.
- Travel up to 10% (domestic and international); role is not 100% remote.
Benefits:
- Premium health, life insurance, disability, retirement with employer match, wellness/support programs, and generous paid time off.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.
The Manager, Regulatory Affairs provides regulatory leadership and execution support for late-stage development programs and helps implement global regulatory strategies from development through registration and lifecycle management. Works with cross-functional teams to support regulatory planning, submission execution, Health Authority interactions, and preparation for major regulatory milestones.
Responsibilities:
- Support implementation of global regulatory strategies for late-stage development and registration activities.
- Represent Regulatory Affairs on cross-functional project teams and provide regulatory input on development, registration, and lifecycle management.
- Coordinate preparation and submission of regulatory applications (INDs, CTAs, amendments, annual reports, briefing packages, NDA/BLA/MAA components).
- Lead regulatory document preparation and collaborate with SMEs for submission milestones and dossier readiness.
- Support Health Authority interactions (meeting requests, briefing documents, responses, post-meeting commitments).
- Partner with Clinical, Nonclinical, CMC, Regulatory Operations, Medical Writing, and Project Management to plan and execute registrations.
- Support submission planning, content development, timeline management, and tracking of deliverables.
- Assist with lifecycle management (post-approval commitments, variations, supplements, labeling updates as applicable).
- Identify regulatory risks and develop mitigation strategies.
- Manage activities by regulatory consultants, contract resources, and external vendors.
- Evaluate emerging regulations/guidance/precedents; support process/template/best-practice improvements.
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences (or related) required; advanced degree preferred.
- 6+ years regulatory affairs experience in pharma/biotech.
- Experience with clinical-stage development and global submissions; working knowledge of FDA/EMA/ICH and other global requirements.
- Experience preparing/supporting IND/CTA submissions; strong understanding of late-stage drug development.
- Experience supporting Phase 3 and global post-approval lifecycle management.
Additional Skills/Requirements (Preferred/Required):
- Knowledge of FDA, EMA, MHRA, PMDA, Health Canada, ICH, and global CMC regulatory requirements.
- Health Authority interaction experience preferred.
- Strong project management/organizational skills; excellent communication.
- Ability to work independently with cross-functional teams; sound regulatory judgment.
- Travel up to 10% (domestic and international); role is not 100% remote.
Benefits:
- Premium health, life insurance, disability, retirement with employer match, wellness/support programs, and generous paid time off.
Application Instructions:
- Apply on an ongoing basis until a candidate is selected.