Travere Therapeutics logo
Travere Therapeutics

In rare for life.

Director, Regulatory Affairs Strategy

ComplianceComplianceFull TimeRemoteLeadTeam 201-500Since 2013H1B No SponsorCompany SiteLinkedIn

Location

California

Posted

1 day ago

Salary

$189K - $246K / year

Seniority

Lead

Bachelor Degree10 yrs expEnglish

Job Description

Director, Regulatory Affairs Strategy

Travere Therapeutics

• 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

Job 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

Benefits

  • 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
  • generous paid time off

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