Director, Regulatory Affairs Strategy

Job 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