Senior Director, Global Regulatory Lead

🔥 17 hours ago

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Perspective Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2023

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $400k Grant on 2024-02

Biotechnology • Healthcare Insurance • Pharmaceuticals

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

• Provides strategic regulatory leadership across radiopharmaceutical clinical development programs • Develops and executes global regulatory strategies • Leads global regulatory submissions in support of clinical development, product registrations, and lifecycle management activities • Drives global regulatory strategy across the entire product lifecycle • Oversees the planning, authoring, execution, and approval of major global regulatory submissions and health authority interactions • Engage and coordinate responses to global regulatory inquiries and health authority questions

🎯 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 • Demonstrated experience supporting radiopharmaceutical, oncology, or other complex drug modalities • Proven track record of leading major global regulatory submissions and approvals • Extensive experience engaging with global health authorities (e.g., FDA, EMA, and other international agencies)

🏖️ Benefits

• Remote, home-based position • Competitive salary • Professional development opportunities