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Executive Director, Global Regulatory Lead
Perspective TherapeuticsExecutive Director providing strategic regulatory leadership across radiopharmaceutical clinical development programs. Lead global regulatory submissions and ensure successful advancement from development through commercialization.
About the role
Key responsibilities & impact- Provide strategic regulatory leadership across radiopharmaceutical clinical development programs
- Develop and execute global regulatory strategies
- Lead global regulatory submissions in support of clinical development, product registrations, and lifecycle management activities
- Translate complex and evolving global regulatory requirements into clear, actionable strategies
- Ensure regulatory alignment across functions and support the successful advancement of radiopharmaceutical programs from early development through commercialization
Requirements
What you’ll need- Bachelor’s degree in a scientific or life sciences discipline required; advanced degree (M.S. or Ph.D.) in biology, chemistry, pharmaceutical sciences, engineering, or a related field strongly preferred
- Regulatory Affairs Certification (RAC) is a plus
- Minimum of 10 years of progressive Regulatory Affairs experience within oncology, specialty therapeutics, and/or complex modalities, with demonstrated regulatory leadership and successful global development outcomes
- Experience supporting radiopharmaceutical, oncology, or other complex drug modalities, with a strong understanding of modality‑specific regulatory considerations
- Proven track record of leading major global regulatory submissions and approvals, including INDs, CTAs, and marketing applications, for clinical‑stage and/or commercial products
- Extensive experience engaging with global health authorities (e.g., FDA, EMA, and other international agencies)
Benefits
Comp & perks- Remote, home-based position
- Ability to sit for extended periods of time while working at a computer and participating in virtual meetings
- Ability to use standard office equipment, including a computer, phone, and video conferencing tools
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategy developmentglobal regulatory submissionsclinical developmentproduct registrationslifecycle managementregulatory leadershipIND submissionsCTA submissionsmarketing applicationsregulatory compliance
Soft Skills
strategic leadershipcommunicationcollaborationproblem-solvingadaptabilitycritical thinkingorganizational skillsinterpersonal skillsdecision-makingnegotiation
Certifications
Regulatory Affairs Certification (RAC)