Senior Director Regulatory Affairs

Director / Sr. Director, Regulatory AffairsTampa, FLA growing and innovative pharmaceutical company focused on specialty and rare disease therapies is seeking a Director / Sr. Director of Regulatory Affairs to join its leadership team.This role will lead regulatory strategy and submissions across development and commercial programs while partnering closely with executive leadership and cross-functional teams.Key Responsibilities:• Lead regulatory strategy for INDs, NDAs, lifecycle management, and FDA interactions• Author and oversee IND submissions, briefing documents, and regulatory dossiers• Partner with Clinical, Medical, Quality, and Commercial teams on development strategy• Support Phase 1–3 clinical development programs and regulatory planning• Lead preparation for FDA meetings and health authority communications• Ensure compliant, high-quality eCTD submissions and regulatory documentation• Monitor regulatory guidance and industry trends to inform business strategy• Identify and mitigate regulatory risks throughout development programs• Mentor and develop junior regulatory professionalsQualifications:• 8–10+ years of Regulatory Affairs experience in pharma or biotech• Direct experience authoring INDs and FDA briefing packages required• Strong knowledge of FDA, ICH, and global regulatory requirements• Experience supporting clinical development programs, including Phase 3 studies• Exceptional regulatory writing, communication, and leadership skills• Bachelor’s degree in Life Sciences required; advanced degree preferredCompensation & Benefits:• Competitive base salary + performance bonus + Equity• Medical, dental, and vision coverage• 401(k) with company match• Paid time off and professional development support