Senior Regulatory Project Lead - Global Submissions

Travere Therapeutics; Boston (MA); On-site; USD 150,000 - 195,000; Full time

Benefits offered by this job

Premium health benefits

Financial well-being programs

Retirement plans with employer match

Generous paid time off

Job summary

Travere Therapeutics is seeking an Associate Director, Regulatory Project Manager to lead global regulatory affairs programs for rare disease therapies. You will partner with Regulatory Leads, Regulatory Operations, and cross-functional teams to manage timelines, submissions, and health authority commitments.

This role emphasizes milestone planning, risk management, dashboards, and mentorship of the RPM team, with travel less than 10% and a base pay range of $150,000.00 - $195,000.00.

Qualifications

• Bachelor's degree in related Life Sciences or related discipline required. MS, PharmD, PhD preferred.

Responsibilities

• Lead regulatory project management activities for one or more global development programs ensuring regulatory plans, timelines, deliverables, and submission activities are aligned with program strategy.
• Partner with Regulatory Leads to drive Global Regulatory Team meeting operations, including agenda planning and action follow-up.
• Develop and maintain integrated regulatory project timelines reflecting global milestones and cross-functional dependencies.
• Oversee planning of major regulatory submissions and maintenance activities (INDs, NDAs, BLAs, supplements, post‑marketing commitments).
• Collaborate with Regulatory Operations, Regulatory Affairs, Clinical Development, Quality, and external partners to ensure timely execution of deliverables.
• Support submission planning and operational readiness by coordinating timelines and review cycles.
• Create and maintain regulatory dashboards and milestone trackers for leadership visibility.
• Identify and mitigate regulatory project risks and resource gaps affecting submissions.
• Support health authority interactions and inspections readiness.

Job description

Travere Therapeutics is seeking an Associate Director, Regulatory Project Manager to lead global regulatory affairs programs for rare disease therapies. You will partner with Regulatory Leads, Regulatory Operations, and cross-functional teams to manage timelines, submissions, and health authority commitments.

This role emphasizes milestone planning, risk management, dashboards, and mentorship of the RPM team, with travel less than 10% and a base pay range of $150,000.00 - $195,000.00.