Regulatory Strategy Lead, Late-Stage Biotech (Remote)

Regulatory Jobs; San Diego (CA); Sur place; USD 116 000 - 151 000; Plein temps

Résumé du poste

Travere Therapeutics is seeking a Manager, Regulatory Affairs to lead regulatory planning and execution for late-stage development and lifecycle programs. You will coordinate global submissions, health authority interactions, and cross-functional team activities to ensure timely approvals.

The role requires strong regulatory knowledge, the ability to collaborate across functions, and experience with IND/CTA submissions and Phase 3 programs.

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• 6+ years of regulatory affairs experience within pharma/biotech.
• Experience supporting global regulatory submissions (IND/CTA).
• Experience with Phase 3/late-stage programs and lifecycle management.

Responsabilités

• Support global regulatory strategies for late-stage programs and registration activities.
• Represent Regulatory Affairs on cross-functional project teams; provide regulatory input.
• Coordinate preparation and submission of regulatory applications (INDs, CTAs, NDA/BLA/MAA).
• Lead preparation of regulatory documents with SMEs for major milestones.
• Support Health Authority interactions and post-meeting commitments.
• Collaborate with Clinical, Nonclinical, CMC, Regulatory Operations, Medical Writing, and PM teams.
• Manage lifecycle management activities including post-approval changes and labeling updates.
• Identify regulatory risks and develop mitigation strategies.
• Oversee regulatory consultants and external vendors as needed.
• Contribute to regulatory intelligence and process improvements.

Connaissances

Regulatory knowledge

Cross-functional collaboration

Communication skills

Travel up to 10%

Formation

Bachelor's degree in Life Sciences

Advanced degree preferred

Description du poste

Travere Therapeutics is seeking a Manager, Regulatory Affairs to lead regulatory planning and execution for late-stage development and lifecycle programs. You will coordinate global submissions, health authority interactions, and cross-functional team activities to ensure timely approvals.

The role requires strong regulatory knowledge, the ability to collaborate across functions, and experience with IND/CTA submissions and Phase 3 programs.