Manager, Regulatory Affairs Strategy
Travere Therapeutics
August 30, 2026
On-site
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 through registration and lifecycle management. Works with cross-functional teams to support regulatory planning, submission execution, Health Authority interactions, and regulatory milestones.
Responsibilities:
- Support implementation of global regulatory strategies for late-stage development and registration.
- Represent Regulatory Affairs on cross-functional teams; provide regulatory input for 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, agency question responses, post-meeting commitments).
- Partner with Clinical, Nonclinical, CMC, Regulatory Operations, Medical Writing, and Project Management.
- Plan submissions; develop content; manage/timelines and track key deliverables.
- Support lifecycle management activities (post-approval commitments, variations, supplements, labeling updates as applicable).
- Identify regulatory risks and develop mitigation strategies.
- Manage regulatory consultants, contract resources, and external vendors as appropriate.
- Evaluate emerging regulations/guidance for regulatory intelligence.
- Support continuous improvement of regulatory processes, templates, and best practices.
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences (or related); equivalent experience may be considered.
- Advanced degree (MS, PharmD, PhD) preferred.
- 6+ years regulatory affairs experience in pharma/biotech.
- Experience with clinical-stage development and global regulatory submissions.
- Working knowledge of FDA, EMA, ICH, and other global requirements.
- Experience preparing/supporting IND/CTA and related submissions.
- Strong understanding of late-stage drug development and regulatory requirements.
- Experience supporting Phase 3/late-stage programs.
- Experience with post-approval change management, comparability, process validation, and lifecycle management.
Additional Skills/Requirements:
- Preferred: experience participating in Health Authority interactions.
- Strong PM/organizational skills; ability to manage multiple priorities.
- Excellent written/verbal communication; ability to work independently and collaborate.
- Demonstrated problem-solving and regulatory judgment.
- Travel up to 10% domestically/internationally.
- Essential function includes face-to-face work/onsite in San Diego; not 100% remote.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness/support programs; life insurance; disability; retirement with employer match; generous paid time off.
- Target Base Pay Range: $116,000 - $151,000.
Application Instructions:
- Travere will accept applications 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 through registration and lifecycle management. Works with cross-functional teams to support regulatory planning, submission execution, Health Authority interactions, and regulatory milestones.
Responsibilities:
- Support implementation of global regulatory strategies for late-stage development and registration.
- Represent Regulatory Affairs on cross-functional teams; provide regulatory input for 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, agency question responses, post-meeting commitments).
- Partner with Clinical, Nonclinical, CMC, Regulatory Operations, Medical Writing, and Project Management.
- Plan submissions; develop content; manage/timelines and track key deliverables.
- Support lifecycle management activities (post-approval commitments, variations, supplements, labeling updates as applicable).
- Identify regulatory risks and develop mitigation strategies.
- Manage regulatory consultants, contract resources, and external vendors as appropriate.
- Evaluate emerging regulations/guidance for regulatory intelligence.
- Support continuous improvement of regulatory processes, templates, and best practices.
Education/Experience Requirements:
- Bachelor’s degree in Life Sciences (or related); equivalent experience may be considered.
- Advanced degree (MS, PharmD, PhD) preferred.
- 6+ years regulatory affairs experience in pharma/biotech.
- Experience with clinical-stage development and global regulatory submissions.
- Working knowledge of FDA, EMA, ICH, and other global requirements.
- Experience preparing/supporting IND/CTA and related submissions.
- Strong understanding of late-stage drug development and regulatory requirements.
- Experience supporting Phase 3/late-stage programs.
- Experience with post-approval change management, comparability, process validation, and lifecycle management.
Additional Skills/Requirements:
- Preferred: experience participating in Health Authority interactions.
- Strong PM/organizational skills; ability to manage multiple priorities.
- Excellent written/verbal communication; ability to work independently and collaborate.
- Demonstrated problem-solving and regulatory judgment.
- Travel up to 10% domestically/internationally.
- Essential function includes face-to-face work/onsite in San Diego; not 100% remote.
Benefits:
- Premium health, financial, work-life/well-being offerings; wellness/support programs; life insurance; disability; retirement with employer match; generous paid time off.
- Target Base Pay Range: $116,000 - $151,000.
Application Instructions:
- Travere will accept applications on an ongoing basis until a candidate is selected.