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Senior Director Regulatory Affairs

Job

NEXT

Tampa, FL (In Person)

Full-Time

Posted 7 weeks ago (Updated 3 weeks ago) • Actively hiring

Expires 7/14/2026

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Job Description

Senior Director Regulatory Affairs at NEXT Senior Director Regulatory Affairs at NEXT in Tampa, Florida Posted in about 23 hours ago.
Type:
full-time
Job Description:
Director / Sr. Director, Regulatory Affairs Tampa, FL A 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 professionals
Qualifications:
  • 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 preferred
Compensation & Benefits:
  • Competitive base salary + performance bonus + Equity
  • Medical, dental, and vision coverage
  • 401(k) with company match
  • Paid time off and professional development support