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Senior Manager, Regulatory Affairs Project Management

Job in Indiana, Indiana County, Pennsylvania, 15705, USA
Listing for: Retrophin, Inc.
Full Time position
Listed on 2026-02-01
Job specializations:
  • Healthcare
    Healthcare Management, Healthcare Administration
  • Management
    Healthcare Management
Salary/Wage Range or Industry Benchmark: 80000 - 100000 USD Yearly USD 80000.00 100000.00 YEAR
Job Description & How to Apply Below
Location: Indiana

Department and Location

Department: 607000 Regulatory - TTSG

Location:

Rapperswil-Jona (SG), Switzerland

About Travere Therapeutics

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference.

We are passionate about what we do.

Position Summary

The Regulatory Project Manager (RPM) is responsible for the end-to-end management of EU and Rest of World (RoW) regulatory activities at Travere Therapeutics. This role works closely with internal and external partners to plan, track, coordinate and report on all regional Health Authority submissions across product life cycles. The RPM owns the Smartsheet ecosystem for submission status, country-specific adaptations from the Global Core Dossier, approval timelines, and Request for Information (RFI) tracking, and communicates progress through dashboards and executive-ready slide materials.

Responsibilities
  • Apply project/program management discipline across multiple assets to enable timely, high-quality regulatory submissions and lifecycle activities
  • Build and maintain integrated regulatory timelines with cross-functional dependencies (CMC, Nonclinical/Clinical, Safety, PV, Labeling, Commercial, Medical)
  • Maintain a country submission tracker covering target/actual submit dates, validation, clock starts/stops, milestones, and approval dates
  • Track submission preparation progress, including but not limited to post-marketing and annual reporting commitments, to ensure timely filing to health authorities
  • Maintain a Global Core Dossier adaptation log per country (module/section level) noting local requirements, deviations, justifications, and source/owner
  • Coordinate with Regulatory Operations on publishing plans, submission readiness, and version control; ensure alignment with eCTD requirements
  • Facilitate Regulatory EU/RoW working sessions: schedule, set agendas with Regulatory Leads, capture/distribute minutes, and drive action item closure
  • Prepare executive-ready updates and slide presentations for governance forums and senior leadership
  • Maintain a structured archive of agendas, minutes, trackers, and key decisions
  • Drive rapid response tasking and cross-functional alignment to meet health authority response timelines; document outcomes and learnings
  • Continuously improve regulatory PM processes and templates; implement SOP/WI compliance in daily operations
Education and Experience Requirements
  • Bachelor’s degree in related Life Sciences discipline. MS, Pharm D, PhD preferred. Equivalent combination of education and applicable job experience may be considered
  • Minimum 6 years of Project Management experience in Biotech or Pharmaceutical industry. Regulatory specific project management experience preferred
  • PMP certification preferred
  • Expertise with timeline development and management software required (e.g., MS Project, Smartsheets)
  • Working knowledge of eCTD structure and publishing workflows; familiarity with RIM systems (e.g., Veeva Vault RIM) is a plus
Additional Skills and Experience
  • Strong professional experience in a similar role within the pharmaceutical industry
  • Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a dynamic, cross-functional teamwork environment
  • Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity
  • Strong interpersonal and organizational skills and excellent verbal and written communication skills are required
  • Successful record of creating and managing complex project plans, timelines, budgets and critical paths
  • Ability to adapt to modification and changes to project plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes
  • Ability to travel 10% domestically and internationally
  • Embodiment of Travere’s Core Values:
    Courage, Community Spirit, Patient Focus and Teamwork

If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to  Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.

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Position Requirements
10+ Years work experience
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