Regulatory Strategy Lead, Late-Stage Biotech (Remote)

Travere Therapeutics; San Diego (CA); Hybrid; USD 116.000 - 151.000; Vollzeit

Benefits dieser Stelle

Premium health benefits

Retirement plans with employer match

Life insurance

Paid time off

Zusammenfassung

Travere Therapeutics is seeking a Manager of Regulatory Affairs Strategy to drive regulatory leadership for late-stage development programs and oversee global submission planning from development through lifecycle management. The role requires strong regulatory knowledge, cross-functional teamwork, and the ability to manage complex submission timelines.

The position involves collaboration with clinical, nonclinical, CMC, regulatory operations, medical writing, and project management teams in a

Qualifikationen

• Bachelor's degree in Life Sciences or related field required.
• Advanced degree (MS/PhD) preferred.
• 6+ years regulatory affairs experience in pharma/biotech.
• Experience with late-stage development programs and global submissions.

Aufgaben

• Support global regulatory strategies for late-stage programs and registrations.
• Represent Regulatory Affairs on cross-functional teams and provide input on development, registration, and lifecycle activities.
• Coordinate preparation and submission of regulatory applications (INDs, CTA, amendments, annual reports, briefing packages, NDA/BLA/MAA).
• Lead preparation of regulatory documents and collaborate with SMEs for major milestones.
• Support Health Authority interactions and post-meeting commitments.
• Partner with Clinical, CMC, Regulatory Operations, Medical Writing, and PM teams for registration planning.
• Assist lifecycle management activities including variations and labeling updates.
• Identify regulatory risks and support mitigation strategies.
• Manage activities of regulatory consultants and vendors.

Kenntnisse

Regulatory strategy

Cross-functional collaboration

Project management

Communication

Travel readiness

Ausbildung

Bachelor's degree in Life Sciences or related field

MS/PhD preferred

Jobbeschreibung

Travere Therapeutics is seeking a Manager of Regulatory Affairs Strategy to drive regulatory leadership for late-stage development programs and oversee global submission planning from development through lifecycle management. The role requires strong regulatory knowledge, cross-functional teamwork, and the ability to manage complex submission timelines.

The position involves collaboration with clinical, nonclinical, CMC, regulatory operations, medical writing, and project management teams in a