Senior Manager, Regulatory Affairs Project Management

Location: Indiana

Senior Manager, Regulatory Affairs Project Management page is loaded## Senior Manager, Regulatory Affairs Project Management locations:
Rapperswil-Jona (SG), Switzerland time type:
Full time posted on:
Posted 4 Days Agojob requisition :
R-100803

Department:607000 Regulatory - TTSG

Location:

Rapperswil-Jona (SG), Switzerland
** 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.

We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.

At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients*.
*** 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.

At Travere, our mission is to identify, develop and deliver life-changing therapies to people living with rare diseases to help them achieve the best possible therapeutic outcomes. Giving patients a chance, providing hope, is what drives us. Travere recognizes that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of patients.

Our work is rewarding, professionally and personally because we are making a difference and we are passionate about what we do. We are seeking talented individuals with an entrepreneurial drive who will thrive in our collaborative, fast-paced environment and share in our mission to help others. We are headquartered in San Diego, CA with an additional offices in Rapperswil, Switzerland, where this role will be located.
** 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…