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