Manager, Regulatory Affairs Strategy
Travere Therapeutics
June 27, 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 contributes to global regulatory strategy implementation from development through registration and lifecycle management. Works with cross-functional teams to support regulatory planning, submission execution, Health Authority interactions, and major regulatory milestones.
Responsibilities:
- Support implementation of global regulatory strategies for late-stage development and registration.
- Represent Regulatory Affairs on cross-functional project teams; provide regulatory input across development, registration, and lifecycle management.
- Coordinate preparation and submission of regulatory applications (INDs, CTAs, amendments, annual reports, briefing packages, NDA/BLA/MAA).
- Lead regulatory document preparation; collaborate with SMEs for submission milestones and 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.
- Support submission planning, content development, timeline management, and tracking deliverables.
- Assist lifecycle management activities (post-approval commitments, variations, supplements, labeling updates).
- Identify regulatory risks and develop mitigation strategies.
- Manage regulatory consultants/contract resources/vendors as appropriate.
- Evaluate emerging regulations/guidance/precedents; improve regulatory processes/templates.
Qualifications/Requirements:
- Bachelor’s degree in Life Sciences or related field required (equivalent education/experience considered).
- MS/PharmD/PhD 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; IND/CTA submission experience.
- Strong late-stage development and drug development regulatory understanding; Phase 3 experience.
- Experience with post-approval change management, comparability, process validation, and lifecycle management.
Additional Skills/Preferred:
- Experience with Health Authority interactions.
- Strong project management, organization, written/verbal communication, regulatory judgment.
- Travel up to 10%.
- Onsite/face-to-face in San Diego required; not 100% remote.
Benefits:
- Premium health, financial, work-life and well-being; wellness/employee support; life insurance; disability; retirement match; generous paid time off.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.
The Manager, Regulatory Affairs provides regulatory leadership and execution support for late-stage development programs and contributes to global regulatory strategy implementation from development through registration and lifecycle management. Works with cross-functional teams to support regulatory planning, submission execution, Health Authority interactions, and major regulatory milestones.
Responsibilities:
- Support implementation of global regulatory strategies for late-stage development and registration.
- Represent Regulatory Affairs on cross-functional project teams; provide regulatory input across development, registration, and lifecycle management.
- Coordinate preparation and submission of regulatory applications (INDs, CTAs, amendments, annual reports, briefing packages, NDA/BLA/MAA).
- Lead regulatory document preparation; collaborate with SMEs for submission milestones and 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.
- Support submission planning, content development, timeline management, and tracking deliverables.
- Assist lifecycle management activities (post-approval commitments, variations, supplements, labeling updates).
- Identify regulatory risks and develop mitigation strategies.
- Manage regulatory consultants/contract resources/vendors as appropriate.
- Evaluate emerging regulations/guidance/precedents; improve regulatory processes/templates.
Qualifications/Requirements:
- Bachelor’s degree in Life Sciences or related field required (equivalent education/experience considered).
- MS/PharmD/PhD 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; IND/CTA submission experience.
- Strong late-stage development and drug development regulatory understanding; Phase 3 experience.
- Experience with post-approval change management, comparability, process validation, and lifecycle management.
Additional Skills/Preferred:
- Experience with Health Authority interactions.
- Strong project management, organization, written/verbal communication, regulatory judgment.
- Travel up to 10%.
- Onsite/face-to-face in San Diego required; not 100% remote.
Benefits:
- Premium health, financial, work-life and well-being; wellness/employee support; life insurance; disability; retirement match; generous paid time off.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected for the position.