Manager, Regulatory Affairs Strategy
Travere Therapeutics
August 09, 2026
Remote friendly (United States)
United States
Corporate Functions
Position Summary:
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 global regulatory strategies for late-stage development and registration.
- Serve as Regulatory Affairs representative on cross-functional 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 components).
- Lead preparation of regulatory documents; collaborate with SMEs for 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 for registration planning/execution.
- Support regulatory submission planning, content development, timeline management, and tracking.
- Support lifecycle management (post-approval commitments, variations, supplements, labeling updates as applicable).
- Identify regulatory risks and develop mitigation strategies.
- Manage regulatory consultants/contract resources/external vendors as appropriate.
- Evaluate emerging regulations/guidance/precedents; improve regulatory processes/templates/best practices.
Qualifications (Required/Preferred):
- Bachelor’s degree in Life Sciences or related field required; advanced degree (MS/PharmD/PhD) preferred.
- 6+ years regulatory affairs experience in pharma/biotech.
- Experience with clinical-stage development and global regulatory submissions; prepare/support IND/CTA submissions.
- Working knowledge of FDA, EMA, ICH, and other global regulatory requirements; Phase 3/late-stage experience.
- Strong understanding of late-stage drug development and regulatory requirements; experience in post-approval change management/lifecycle activities preferred.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness/support programs; life insurance; disability; retirement plans with employer match; generous paid time off.
Application instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.
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 global regulatory strategies for late-stage development and registration.
- Serve as Regulatory Affairs representative on cross-functional 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 components).
- Lead preparation of regulatory documents; collaborate with SMEs for 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 for registration planning/execution.
- Support regulatory submission planning, content development, timeline management, and tracking.
- Support lifecycle management (post-approval commitments, variations, supplements, labeling updates as applicable).
- Identify regulatory risks and develop mitigation strategies.
- Manage regulatory consultants/contract resources/external vendors as appropriate.
- Evaluate emerging regulations/guidance/precedents; improve regulatory processes/templates/best practices.
Qualifications (Required/Preferred):
- Bachelor’s degree in Life Sciences or related field required; advanced degree (MS/PharmD/PhD) preferred.
- 6+ years regulatory affairs experience in pharma/biotech.
- Experience with clinical-stage development and global regulatory submissions; prepare/support IND/CTA submissions.
- Working knowledge of FDA, EMA, ICH, and other global regulatory requirements; Phase 3/late-stage experience.
- Strong understanding of late-stage drug development and regulatory requirements; experience in post-approval change management/lifecycle activities preferred.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness/support programs; life insurance; disability; retirement plans with employer match; generous paid time off.
Application instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.