Senior Director, Global Regulatory Lead
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Job Description
Senior regulatory leader advancing Perspective Therapeutics’ radiopharmaceutical clinical programs and commercial launches. Leading global strategies, submissions, health authority interactions, and regulatory teams.
Responsibilities:
- Provide strategic regulatory leadership across radiopharmaceutical clinical development programs and future commercial launches
- Develop and execute global regulatory strategies and lead global regulatory submissions
- Serve as the single point of accountability for global regulatory strategy for assigned development programs
- Develop and maintain global regulatory roadmaps integrating clinical, CMC/radiochemistry, non-clinical, quality, manufacturing, companion diagnostic, and lifecycle considerations
- Shape global regulatory pathways, including expedited programs, dose and regimen optimization, radiopharmaceutical guidance, and regulatory interactions
- Drive regulatory strategy across initial approvals, post-marketing commitments, pediatric development, label expansion, and global market expansion
- Lead, mentor, and develop Global Regulatory Affairs team members and provide matrix leadership
- Oversee IND, CTA, CTIS, NDA, MAA, pediatric plan, amendment, and safety update submissions
- Lead responses to global regulatory inquiries and health authority questions
- Lead strategy, content development, and execution for global health authority interactions
- Serve as senior regulatory representative and spokesperson for the company
- Monitor global regulatory frameworks, emerging guidance, and precedent decisions
- Translate regulatory intelligence into development, risk management, and portfolio decision-making
- Ensure high-quality, consistent, and compliant regulatory documentation
- Partner with Regulatory Operations on submission planning, publishing, tracking, lifecycle management, and archival
- Oversee IMPD and CMC module alignment with clinical supply, radiochemistry, analytical methods, stability, and isotope lifecycle considerations
- Provide strategic oversight of external regulatory consultants, CROs, and specialized vendors
Requirements:
- 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
- Experience supporting radiopharmaceutical, oncology, or other complex drug modalities
- Track record leading major global regulatory submissions and approvals, including INDs, CTAs, and marketing applications
- Extensive experience engaging with global health authorities, including FDA and EMA
- Strong understanding of global regulatory requirements for oncology and complex therapeutic modalities
- Broad knowledge of drug development, regulatory compliance, commercialization, and lifecycle management
- Ability to lead, influence, and align cross-functional teams and senior stakeholders
- Project and program leadership skills, including managing priorities, timelines, dependencies, and risks
- Ability to travel for business as required, up to 20%
- Ability to work regular business hours with flexibility across time zones
- Strong attention to detail and accurate information management
- Ability to work independently and effectively in a remote, collaborative, team-based setting
- Willingness to complete required corporate, compliance, and systems training
Benefits:
- Equal employment opportunities and anti-discrimination protections
- Remote, home-based work arrangement
- Flexibility to support meetings across time zones
- Standard office equipment and video conferencing tools
- Corporate, compliance, and systems training
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