Director, Regulatory Affairs Strategy

Position Summary

The Director, Regulatory Affairs Strategy is responsible for developing and executing global regulatory strategies for Phase 2 and Phase 3 development programs to support successful clinical development, registration, and commercialization of investigational products. This individual serves as the regulatory lead for assigned programs and provides strategic guidance to cross-functional teams, ensuring alignment with global regulatory requirements and corporate objectives.

Responsibilities

• Regulatory Strategy & Leadership
  • Develop and lead global regulatory strategies for Phase 2 and Phase 3 clinical development programs.
  • Provide regulatory guidance on clinical development plans, pivotal trial design, statistical considerations, and registration pathways.
  • Evaluate regulatory risks and opportunities and develop mitigation strategies to support program objectives.
  • Lead regulatory planning for major milestones, including End-of-Phase 2 meetings, Scientific Advice procedures, Breakthrough Therapy Designation, Fast Track, PRIME, Accelerated Approval, Priority Review, and marketing applications.
  • Serve as the regulatory representative on cross-functional program teams and governance committees.
• Health Authority Interactions
  • Lead preparation, coordination, and execution of global regulatory agency meetings and interactions.
  • Develop briefing documents, regulatory questions, meeting strategies, and response packages.
  • Represent the company during regulatory agency meetings and negotiations.
  • Ensure alignment of regulatory strategy across regions while addressing local market requirements.
• Regulatory Submissions
  • Oversee the preparation and submission of global regulatory documents, including:
  • INDs and IND amendments
  • Clinical Trial Applications (CTAs)
  • Annual reports and Development Safety Update Reports (DSURs)
  • Pediatric plans and orphan drug submissions
  • NDA, BLA, MAA, and other marketing applications
  • Review and approve key submission documents to ensure regulatory compliance, scientific integrity, and strategic consistency.
• Cross-Functional Collaboration
  • Collaborate with Clinical, Medical, CMC, Nonclinical, and Commercial teams to integrate regulatory considerations into development plans.
  • Provide regulatory leadership for label development and commercialization planning.
  • Support due diligence activities, business development initiatives, and portfolio evaluations as needed.
  • Mentor and develop regulatory staff and contribute to building organizational regulatory capabilities.
• Regulatory Intelligence & Compliance
  • Monitor evolving global regulatory requirements, guidance documents, and industry trends.
  • Assess potential impact of regulatory changes on development programs and advise leadership accordingly.
  • Ensure compliance with applicable regulatory regulations, guidelines, and company procedures.

Education/Experience Requirements

• Bachelor’s degree in a scientific or related field required.
• Equitable combination of skills and relevant experience are also considered.
• Advanced degree in Life Sciences, Pharmacy, Medicine, Regulatory Affairs, or related discipline preferred (PhD, PharmD, MD, or MS).
• 10+ years of progressive regulatory affairs experience within the pharmaceutical, biotechnology, or life sciences industry.
• Significant experience leading regulatory strategy for Phase 2 and Phase 3 development programs.
• Demonstrated success managing interactions with FDA and other major global health authorities.
• Experience supporting or leading NDA, BLA, MAA, or equivalent marketing application submissions.
• Strong understanding of global drug development, regulatory frameworks, and clinical trial regulations.
• Experience in one or more therapeutic areas such as oncology, rare disease, immunology, neuroscience, or metabolic disease preferred.

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.
• Exceptional communication, negotiation, and influencing skills.
• Ability to effectively manage complex regulatory issues in a fast-paced environment.
• Strong leadership and cross-functional collaboration capabilities.
• Strong strategic thinking with strong business and scientific acumen, problem-solving, and decision-making capabilities.
• Strong interpersonal and proactive approach.
• Able to work both independently and in a team environment.
• Detail-oriented, with good organizational, prioritization, and time management proficiencies.
• Proven ability to manage multiple priorities in a fast-paced environment.
• Able to work effectively across global time zones when necessary.
• Some travel (10-15%) may be required, with the potential for travel occurring over weekends.

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: $189,000.00 - $246,000.00