Associate Director, Project Manager - Regulatory Affairs

Be part of a global team 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, delivering rewarding professional and personal experiences as we work to identify, develop, and deliver life-changing therapies.

About the role

The Associate Director, Regulatory Project Manager (RPM) leads and coordinates 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. The position works with 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 align 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 reflecting 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.
• Perform additional duties as assigned.

Requirements

• Bachelor’s degree in Life Sciences or a related discipline required; MS, PharmD, or PhD preferred. Equivalent combination of education and applicable job experience may be considered.
• 8+ years of project management experience in the biotech or pharmaceutical industry; regulatory-specific project management experience preferred.
• PMP certification strongly preferred.
• Expertise with timeline development and management software (e.g., Smartsheets, MS Project).
• Strong understanding of global regulatory affairs, submission requirements, and compliance processes for rare disease therapies.
• Ability to travel less than 10% domestically and internationally.
• All positions require the ability to perform face-to-face work with colleagues and/or onsite in San Diego; no role is 100% remote.

Skills

• Driven, intelligent, and passionate about making a difference for patients with rare diseases.
• Well-organized with the ability to multitask, prioritize, and manage shifting responsibilities in a dynamic, cross-functional team 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 Travere's patient-first mission.
• Proven ability to create and manage complex project plans, timelines, budgets, and critical paths, with flexibility to adapt to changes and implement new strategies.
• Embodies Travere’s core values: Courage, Community Spirit, Patient Focus, and Teamwork.

Benefits

• Premium health, financial, work-life, and well-being offerings for eligible employees and dependents.
• Wellness and employee support programs.
• Life insurance and disability coverage.
• Retirement plans with employer match.
• Generous paid time off.

Pay

Competitive compensation package including base pay, short-term incentive, and long-term incentive (company stock). Target base pay range: $150,000 – $195,000. Actual pay offered will depend on the candidate’s experience, education, skills, and location.