Senior Director, Global Regulatory Lead

🔥 1 minute ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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Perspective Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2023

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 $400k Grant on 2024-02

Healthcare • Manufacturing • Biotechnology

Perspective Therapeutics is a biotechnology company focused on developing innovative cancer treatments through a unique class of theranostics. Their proprietary technologies enable the targeting of specific tumors for treatment while minimizing toxicity to healthy tissues. By utilizing radiation, radiopharmaceuticals, and advanced imaging technologies, they aim to improve treatment efficacy and provide better outcomes for cancer patients.

📋 Description

• 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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