Associate Director, Project Manager - Regulatory Affairs

Travere Therapeutics; United States; On-site; USD 150,000 - 230,000; Full time

Job summary

Travere Therapeutics seeks an Associate Director, Regulatory Project Manager to lead global regulatory activities and ensure submissions align with development plans. Remote in San Diego is supported, with limited travel to support cross-functional teams.

You will oversee integrated timelines, mentor staff, and drive process improvements while coordinating across Regulatory Affairs, Clinical Development, CMC, Quality and Commercial to ensure compliance and timely filings.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 8+ years of project management experience in biotech/pharma, with regulatory project management preferred.
• PMP certification highly desired.

Responsibilities

• Develop and manage integrated regulatory timelines.
• Facilitate cross-functional collaboration across Regulatory Affairs, Clinical Development, CMC, Quality, Commercial.
• Oversee submission planning (INDs, NDAs, BLAs, post-marketing reports).
• Track milestones and support agency interactions.
• Drive process improvements and mentor team members.

Skills

Regulatory project management

Cross-functional collaboration

Submission planning

Mentoring

Education

Bachelor's degree in Life Sciences or related

PMP certification

Tools

Smartsheets

MS Project

Job description

Role: Associate Director, Regulatory Project Manager at Travere Therapeutics, leading global regulatory activities to ensure compliance and support submissions for rare disease therapies.

Responsibilities

• develop and manage integrated regulatory timelines
• facilitate cross-functional collaboration across departments (Regulatory Affairs, Clinical Development, CMC, Quality, Commercial)
• oversee submission planning (INDs, NDAs, BLAs, post-marketing reports)
• track milestones
• and support agency interactions
• Drive process improvements and mentor team members.

Requirements

• Bachelor’s degree in Life Sciences or related
• 8+ years of project management experience in biotech/pharma, with regulatory project management preferred
• PMP certification highly desired.

High-Value

• rare disease therapies
• global regulatory submissions
• lifecycle management
• cross-functional coordination
• experience with regulatory tools (e.g., Smartsheets, MS Project)

Work Setup

remote in San Diego with less than 10% travel domestically and internationally.