Associate Director, Project Manager Regulatory Affairs

Department:

Location:

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 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 Associate Director Regulatory Project Manager (RPM) at Travere Therapeutics is responsible for leading and coordinating global regulatory affairs activities to ensure compliance with health authority requirements. This role supports regulatory submissions for investigational and commercial rare disease therapies facilitates cross-functional collaboration and manages timelines to achieve company objectives in a fast-paced patient-focused environment.

This position works with the Regulatory Affairs Strategy leaders to create regulatory project timelines and dashboards schedule cross-functional meetings and track regulatory commitments.

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.
• Support submission planning and operational readiness by coordinating content planning submission timelines document ownership review cycles and Vault RIM-related activities in partnership with Regulatory Operations and Regulatory Leads.
• Create and maintain regulatory dashboards milestone trackers and status reports to provide visibility to Regulatory Affairs leadership program teams and senior management on progress risks issues and upcoming deliverables.
• Identify communicate and help mitigate regulatory project risks timeline constraints resource gaps and cross-functional dependencies that may impact submission readiness health authority commitments or program execution.
• Support preparation for health authority interactions advisory committee activities inspection readiness audits and regulatory responses by coordinating timelines materials contributors and action follow-up.
• Drive continuous improvement of regulatory project management processes tools templates meeting operations dashboards and ways of working to improve consistency efficiency and scalability across programs.
• Manage regulatory project documentation and ensure key decisions action items timelines submission plans and deliverables are appropriately captured maintained and accessible in designated systems or repositories.
• Provide leadership mentoring and guidance to regulatory project management team members and cross-functional partners; may manage direct reports or support resource planning across multiple programs as the function evolves.
• Additional duties assigned as needed.

Education/Experience Requirements:

• Bachelors degree in related Life Sciences or related discipline required. MS Pharm D PhD preferred. Equivalent combination of education and applicable job experience may be considered.
• 8 years of Project Management experience in Biotech or Pharmaceutical industry. Regulatory specific project management experience preferred.
• PMP certification is strongly preferred.
• Expertise with timeline development and management software required (e.g. Smartsheets MS Project).

Additional Skills/Experience:

• The ideal candidate will embody Traveres core values: Courage Community Spirit Patient Focus and Teamwork.
• Driven intelligent passionate about making a difference for patients with rare diseases.
• Strong understanding of global regulatory affairs submission requirements and compliance processes for rare disease therapies.
• Well organized with the ability to multitask prioritize and manage shifting responsibilities in a dynamic cross-functional teamwork environment.
• Excellent project management skills including scheduling risk management and stakeholder coordination in a fast-paced biotech setting.
• Strong communication organizational and problem-solving skills to drive regulatory initiatives aligned with Traveres patient-first mission.
• 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 less than 10% domestic and internationally.
• All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

Total Rewards Offerings:
Travere provides comprehensive total rewards offerings that demonstrate our commitment as a diverse equitable people-centric and pay-for-performance organization.

Benefits: Our benefits include premium health financial work-life and well-being offerings for eligible employees and dependents wellness and employee support programs life insurance disability retirement plans with employer match and generous paid time off.

Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock) designed to recognize retain and reward employees.

Target Base Pay Range:

*This information is current as of the date of this posting and may be modified in the future. Actual pay offered to a candidate will depend on a variety of factors including the candidates experience education skills and location.

Travere will accept applications on an ongoing basis until a candidate is selected for the position.

Travere Therapeutics Inc. is an EEO/AA/Veteran/Disability Employer.

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.