Job Description

Director, Regulatory Affairs

Location: Tampa, Florida

(Relocation assistance available for eligible candidates)

Join a global life sciences organization and lead regulatory strategy that supports the development and delivery of transformative medicines. This role drives regulatory excellence, ensures compliance with global requirements, and supports successful product submissions across multiple regions.

What You’ll Do

• Monitor global and regional regulatory requirements to ensure compliance and identify emerging risks.
• Represent the organization in interactions with Health Authorities and lead regulatory negotiations.
• Develop and execute regulatory strategies to support new submissions and ongoing lifecycle management.
• Oversee preparation and review of Chemistry, Manufacturing, and Controls (CMC) documentation.
• Partner with Quality, Operations, and R&D to align regulatory approaches with business objectives.
• Lead and mentor the Regulatory Affairs team, supporting professional development and high performance.
• Drive continuous improvement across regulatory processes.

What We’re Looking For

• Bachelor’s degree in Chemistry, Biochemistry, or related discipline; advanced degree preferred.
• 10+ years of experience in Regulatory Affairs or related pharmaceutical/biotech roles.
• Strong expertise in CMC regulatory requirements and submission processes.
• Proven leadership ability with strong collaboration and stakeholder-influencing skills.
• Excellent organizational and communication skills.
• Experience managing complex projects within tight timelines.
• Knowledge of global regulatory frameworks (e.g., FDA, EMA, Health Canada).

What You’ll Get

• A dynamic, agile work environment.
• An inclusive, ethical company culture.
• Competitive compensation programs that reward high performance.
• Comprehensive benefits (varies by location and role).

If you’re passionate about advancing life-changing therapies and shaping the future of regulatory strategy, this role offers the opportunity to make a global impa

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