Manager, Regulatory Affairs Strategy
Travere Therapeutics
June 27, 2026
Remote friendly (United States)
United States
Corporate Functions
Position Summary:
The Manager, Regulatory Affairs provides regulatory leadership and execution support for late-stage development programs and 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 key regulatory milestones.
Responsibilities:
- Support global regulatory strategies for late-stage development and registration activities.
- Represent Regulatory Affairs on cross-functional teams; provide regulatory input across development/registration/lifecycle.
- Coordinate preparation and submission of INDs, CTAs, amendments, annual reports, briefing packages, and marketing components (NDA, BLA, MAA).
- Lead regulatory document preparation and collaborate for dossier readiness.
- Support Health Authority interactions (meeting requests, briefings, responses, commitments).
- Partner with Clinical, Nonclinical, CMC, Regulatory Operations, Medical Writing, and Project Management.
- Plan and manage submission content/timelines; track key deliverables.
- Support lifecycle management (post-approval commitments, variations, supplements, labeling updates).
- Identify regulatory risks and develop mitigation strategies.
- Manage consultants/contract resources/vendors as needed.
- Evaluate emerging regulations/guidance; improve regulatory processes/templates.
Education/Experience (Required/Preferred):
- Required: BS in Life Sciences or related field (or equivalent combination).
- Preferred: MS/PharmD/PhD or equivalent.
- 6+ years regulatory affairs in pharma/biotech; clinical-stage and global submission experience.
- Working knowledge of FDA/EMA/ICH and global requirements; IND/CTA submission experience; late-stage/Phase 3 experience.
Additional Skills:
- Understanding of FDA/EMA/MHRA/PMDA/Health Canada/ICH and global CMC requirements.
- Preferred: Health Authority interaction experience.
- Strong PM, organization, written/verbal communication, independent work with cross-functional collaboration, sound regulatory judgment; travel up to 10%.
Benefits (explicitly stated):
- Premium health; wellness/support programs; life insurance; disability; retirement with match; generous paid time off.
Application Instructions:
- Accepts applications on an ongoing basis.
- Accommodation requests: accommodations@travere.com.
The Manager, Regulatory Affairs provides regulatory leadership and execution support for late-stage development programs and 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 key regulatory milestones.
Responsibilities:
- Support global regulatory strategies for late-stage development and registration activities.
- Represent Regulatory Affairs on cross-functional teams; provide regulatory input across development/registration/lifecycle.
- Coordinate preparation and submission of INDs, CTAs, amendments, annual reports, briefing packages, and marketing components (NDA, BLA, MAA).
- Lead regulatory document preparation and collaborate for dossier readiness.
- Support Health Authority interactions (meeting requests, briefings, responses, commitments).
- Partner with Clinical, Nonclinical, CMC, Regulatory Operations, Medical Writing, and Project Management.
- Plan and manage submission content/timelines; track key deliverables.
- Support lifecycle management (post-approval commitments, variations, supplements, labeling updates).
- Identify regulatory risks and develop mitigation strategies.
- Manage consultants/contract resources/vendors as needed.
- Evaluate emerging regulations/guidance; improve regulatory processes/templates.
Education/Experience (Required/Preferred):
- Required: BS in Life Sciences or related field (or equivalent combination).
- Preferred: MS/PharmD/PhD or equivalent.
- 6+ years regulatory affairs in pharma/biotech; clinical-stage and global submission experience.
- Working knowledge of FDA/EMA/ICH and global requirements; IND/CTA submission experience; late-stage/Phase 3 experience.
Additional Skills:
- Understanding of FDA/EMA/MHRA/PMDA/Health Canada/ICH and global CMC requirements.
- Preferred: Health Authority interaction experience.
- Strong PM, organization, written/verbal communication, independent work with cross-functional collaboration, sound regulatory judgment; travel up to 10%.
Benefits (explicitly stated):
- Premium health; wellness/support programs; life insurance; disability; retirement with match; generous paid time off.
Application Instructions:
- Accepts applications on an ongoing basis.
- Accommodation requests: accommodations@travere.com.