Manager, Regulatory Affairs Strategy

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.

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.
• Carefully 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.
• Aid in 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.

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.
• Able to work independently while collaborating effectively within cross-functional teams.
• Demonstrated problem-solving skills and sound regulatory judgment.
• Able to travel up to 10% domestically and internationally.