Senior Director, Global Regulatory Lead

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

📋 Description

• Offers strategic regulatory leadership throughout radiopharmaceutical clinical development initiatives.

• Formulates and implements global regulatory strategies.

• Oversees global regulatory submissions to facilitate clinical development, product registrations, and lifecycle management efforts.

• Guides global regulatory strategy throughout the complete product lifecycle.

• Manages the planning, drafting, execution, and approval of significant global regulatory submissions and interactions with health authorities.

• Engages and coordinates responses to inquiries from global regulatory bodies and health authority questions.

⛳️ 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 discipline is strongly preferred.

• Regulatory Affairs Certification (RAC) is advantageous.

• At least 10 years of progressive experience in Regulatory Affairs within oncology, specialty therapeutics, and/or complex modalities.

• Proven experience in supporting radiopharmaceuticals, oncology, or other intricate drug modalities.

• A demonstrated history of leading significant global regulatory submissions and securing approvals.

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

🏝️ Benefits

• Remote, home-based position.

• Competitive salary.

• Opportunities for professional development.