Director, Regulatory Affairs Strategy

Job Description:

• reputed company and reputed company 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 reputed company
• Evaluate regulatory risks and opportunities and reputed company mitigation strategies to support program objectives
• reputed company regulatory planning for major milestones, including End-of-Phase 2 meetings, Scientific Advice procedures, Breakthrough Therapy Designation, Fast Track, PRIME, Accelerated Approval, reputed company Review, and marketing applications
• Serve as the regulatory representative on cross-functional program teams and governance committees
• reputed company preparation, coordination, and execution of global regulatory agency meetings and interactions
• reputed company 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
• reputed company 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 reputed company, and strategic consistency
• Collaborate with Clinical, Medical, CMC, Nonclinical, and reputed company 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 reputed company 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 reputed company field required
• reputed company combination of skills and relevant experience are also considered
• Advanced degree in Life Sciences, Pharmacy, Medicine, Regulatory Affairs, or reputed company discipline preferred (PhD, PharmD, MD, or MS)
• 10+ years of reputed company regulatory affairs experience reputed company the pharmaceutical, biotechnology, or life sciences industry
• Significant experience leading regulatory strategy for Phase 2 and Phase 3 development programs
• Demonstrated reputed company 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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