Director of Regulatory Affairs

Role: Lead regulatory strategy and submission activities for a biopharma company focused on rare diseases, managing INDs, FDA meeting packages, and regulatory compliance. Responsibilities: develop integrated regulatory and clinical development strategies for Phase 2/3 programs, author and oversee IND submissions, prepare FDA briefing documents, and ensure regulatory alignment across clinical and nonclinical teams. Serve as primary author for regulatory documents, lead agency interactions, and manage cross-functional collaboration with R&D, Quality, and Legal. Monitor evolving regulatory guidance and advise leadership on risks and opportunities. Provide regulatory mentorship and oversee submission quality, including eCTD formatting. Requirements: Bachelor's in Life Sciences, 8-10+ years of regulatory affairs experience supporting clinical programs, with proven expertise in IND submissions and FDA interactions. Skills: strong knowledge of ICH, FDA, EMA guidelines; proficiency in regulatory software; excellent regulatory writing and cross-functional communication skills. Preferred: advanced degrees (MS, PhD, PharmD), RAC certification. HighValue: experience with Phase 3 development, biologics or small molecules, regulatory submissions, and global regulatory standards. WorkSetup: based in Tampa, FL with potential for onsite or hybrid work.