Senior Regulatory Project Lead - Remote

Travere Therapeutics; San Diego (CA); Hybrid; USD 150,000 - 195,000; Full time

Job summary

Travere Therapeutics in San Diego is seeking an Associate Director, Regulatory Project Manager to lead global regulatory affairs activities for rare disease programs. You will coordinate timelines, cross‑functional teams, and submission plans to meet health authority requirements in a fast-paced, patient‑focused environment.

The role requires 8+ years of biotech/pharma project management, a life sciences degree (MS/PhD preferred), PMP preferred, and experience with Smartsheets or MS Project.

Qualifications

• 8+ years of project management experience in biotech or pharmaceutical industry.
• Regulatory project management experience preferred.
• PMP certification strongly preferred.
• Expertise with timeline development and management software required (e.g., Smartsheets, MS Project).

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 and corporate priorities.
• Partner closely with Regulatory Leads to drive Global Regulatory Team meeting operations, including agenda planning, decision tracking, meeting documentation, and follow‑up on key actions and commitments.
• Develop, maintain, and manage integrated regulatory project timelines that reflect global health authority milestones, cross‑functional dependencies, submission deliverables, and key decision points across the product lifecycle.
• Oversee planning and tracking of major regulatory submissions and maintenance activities, including INDs, NDAs, BLAs, supplements, annual reports, DSURs, post‑marketing commitments, health authority responses, and other regulatory deliverables.
• Collaborate with Regulatory Operations, Regulatory Affairs, Clinical Development, Clinical Operations, CMC, Biostatistics, Medical Writing, Quality, Commercial and external partners/vendors to ensure timely and high‑quality execution of regulatory deliverables.

Skills

Regulatory project management

Timeline development

Cross-functional collaboration

Leadership

Risk management

Education

Bachelor's degree in Life Sciences or related discipline

MS/PhD preferred

Tools

Smartsheets

MS Project

Job description

Travere Therapeutics in San Diego is seeking an Associate Director, Regulatory Project Manager to lead global regulatory affairs activities for rare disease programs. You will coordinate timelines, cross‑functional teams, and submission plans to meet health authority requirements in a fast-paced, patient‑focused environment.

The role requires 8+ years of biotech/pharma project management, a life sciences degree (MS/PhD preferred), PMP preferred, and experience with Smartsheets or MS Project.