Executive Director, Global Regulatory Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic regulatory guidance across clinical development programs for radiopharmaceuticals.

• Develop and implement global regulatory strategies.

• Lead global regulatory submissions to support clinical development, product registrations, and lifecycle management activities.

• Convert complex and evolving global regulatory requirements into clear and actionable strategies.

• Ensure regulatory alignment across various functions and facilitate the successful progression of radiopharmaceutical programs from early development to commercialization.

⛳️ Requirements

• A Bachelor’s degree in a scientific or life sciences field is required; an advanced degree (M.S. or Ph.D.) in biology, chemistry, pharmaceutical sciences, engineering, or a related area is strongly preferred.

• Regulatory Affairs Certification (RAC) is advantageous.

• A minimum of 10 years of progressive experience in Regulatory Affairs within oncology, specialty therapeutics, and/or complex modalities, showcasing regulatory leadership and successful global development outcomes.

• Experience in supporting radiopharmaceuticals, oncology, or other complex drug modalities, with a robust understanding of modality-specific regulatory considerations.

• A proven history of leading significant global regulatory submissions and approvals, including INDs, CTAs, and marketing applications for clinical-stage and/or commercial products.

• Extensive experience interacting with global health authorities (e.g., FDA, EMA, and other international agencies).

🏝️ Benefits

• This is a remote, home-based position.

• Opportunity to sit for extended periods while working on a computer and participating in virtual meetings.

• Capability to utilize standard office equipment, including a computer, phone, and video conferencing tools.