Director, Regulatory Affairs Strategy

Department: 107000 Regulatory

Location:

San Diego, USA
- Remote

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.

The Director partners closely with Clinical Development, Clinical Operations, Medical Affairs, Biostatistics, CMC, Quality, Nonclinical, Commercial, and Executive Leadership to drive regulatory excellence throughout late-stage development. The role requires extensive experience interacting with global health authorities, including the FDA, EMA, and other regulatory agencies.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• The ideal candidate will embody Travere's core values:
  Courage, Community Spirit, Patient Focus, and Teamwork.
• Driven, intelligent, and 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…