Director, Regulatory Affairs Strategy

🔥 1 minute ago

🏄 California – Remote

🏄 California – Remote

💵 $189k - $246k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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Travere Therapeutics

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Travere Therapeutics is a biopharmaceutical company committed to identifying, developing, and delivering life-changing therapies for people living with rare diseases, particularly those related to rare kidney and metabolic disorders. The company has a strong focus on advancing science in these fields, with a pipeline that includes treatments for conditions such as IgA nephropathy and focal segmental glomerulosclerosis. With the full U. S. FDA approval of its non-immunosuppressive treatment for IgA nephropathy, Travere Therapeutics continues to set new standards of care. The company collaborates with the rare kidney disease community, including patient advocacy organizations and clinical trial investigators, to bring hope to patients with these serious conditions.

📋 Description

• 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

🎯 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