Manager, Regulatory Affairs Strategy

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 work both professionally and personally. Our mission is to identify, develop, and deliver life-changing therapies, guided by values centered on patients, courage, community, and collaboration. We aim to become a leading biopharmaceutical company dedicated to innovation and hope for the global rare disease community.

About the role

The Manager, Regulatory Affairs provides regulatory leadership and execution support for late-stage development programs and contributes to the implementation of global regulatory strategies from development through registration and lifecycle management activities. This role works closely with cross-functional teams to support regulatory planning, submission execution, Health Authority interactions, and preparation for major regulatory milestones, including marketing applications. The Manager serves as a key regulatory representative on assigned project teams, driving regulatory deliverables, coordinating submission activities, and ensuring compliance with applicable regulatory requirements.

Responsibilities

• Support implementation of global regulatory strategies for late-stage development programs and registration activities.
• Represent Regulatory Affairs on cross-functional project teams and provide regulatory input on development, registration, and lifecycle management activities.
• Coordinate preparation and submission of regulatory applications, including INDs, CTAs, amendments, annual reports, briefing packages, and marketing application components (e.g., NDA, BLA, MAA).
• Lead preparation of regulatory documents and collaborate with subject matter experts to support major submission milestones and dossier readiness activities.
• Support Health Authority interactions, including preparation of meeting requests, briefing documents, responses to agency questions, and post-meeting commitments.
• Partner with Clinical, Nonclinical, CMC, Regulatory Operations, Medical Writing, and Project Management teams to support registration planning and execution.
• Support regulatory submission planning, content development, timeline management, and tracking of key registration deliverables.
• Assist with regulatory activities related to lifecycle management, including post-approval commitments, variations, supplements, and labeling updates, as applicable.
• Identify regulatory risks and support development of mitigation strategies to support program objectives and timelines.
• Manage activities performed by regulatory consultants, contract resources, and external vendors, as appropriate.
• Contribute to regulatory intelligence efforts by evaluating emerging regulations, guidance documents, and precedents relevant to development and registration programs.
• Support development and continuous improvement of regulatory processes, templates, and best practices.
• Additional duties assigned as needed.

Requirements

• Bachelor's degree in Life Sciences or related field required. Equivalent combination of education and applicable job experience may be considered.
• Advanced degree (MS, PharmD, PhD, or equivalent) preferred.
• 6+ years of regulatory affairs experience within the pharmaceutical or biotechnology industry.
• Experience supporting clinical-stage development programs and global regulatory submissions.
• Working knowledge of FDA, EMA, ICH, and other applicable global regulatory requirements.
• Experience preparing or supporting IND, CTA, and related regulatory submissions.
• Strong understanding of drug development and regulatory requirements for late-stage development programs.
• Experience supporting Phase 3 and late-stage development programs.
• Experience supporting global post-approval change management, comparability assessments, process validation, and lifecycle management activities.

Skills

• Embodies Travere's core values: Courage, Community Spirit, Patient Focus, and Teamwork.
• Driven, intelligent, passionate about making a difference for patients with rare diseases.
• Understanding of FDA, EMA, MHRA, PMDA, Health Canada, ICH, and global CMC regulatory requirements.
• Experience participating in Health Authority interactions preferred.
• Knowledge of FDA, EMA, ICH, and other applicable regulatory requirements and guidance related to clinical development and regulatory submissions.
• Experience supporting registration planning, dossier development, lifecycle management, or post-approval regulatory activities strongly preferred.
• Strong project management and organizational skills with the ability to manage multiple priorities simultaneously.
• Excellent written and verbal communication skills.
• Ability to work independently while collaborating effectively within cross-functional teams.
• Demonstrated problem-solving skills and sound regulatory judgment.
• Ability to travel up to 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 expected to be 100% remote.

Benefits

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

• 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

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: $116,000.00 - $151,000.00. Actual pay offered to a candidate will depend on factors including the candidate’s experience, education, skills, and location.