Position Summary:
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 and is responsible for driving regulatory deliverables, coordinating submission activities, and ensuring compliance with applicable regulatory requirements. This position requires strong regulatory knowledge, cross-functional collaboration, and the ability to operate effectively within a dynamic, matrixed environment.
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.
Education/Experience 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.
Additional Skills/Experience/Requirements:
- The ideal candidate will embody 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 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.
