Director, Regulatory Affairs – Market Products, Radiopharma

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

📋 Description

• Formulate and implement the global lifecycle regulatory strategy in alignment with corporate, portfolio, and product goals.

• Serve as a strategic collaborator with senior leadership, conveying risks, opportunities, and regulatory scenarios.

• Lead, mentor, and cultivate a high-performing global regulatory team.

• Manage all post-approval regulatory activities, such as variations, renewals, and regulatory commitments.

• Direct regulatory strategy for post-approval modifications, including impact assessments, pathway optimization, and risk management.

• Ensure adherence to global regulatory standards and the evolving expectations of health authorities.

• Collaborate with RA-CMC to synchronize regulatory strategies for technical and manufacturing adjustments.

• Guarantee the timely and high-quality execution of lifecycle submissions through efficient planning, monitoring, and team accountability.

⛳️ Requirements

• Bachelor’s degree or higher in Life Sciences, Pharmacy, Chemistry, or a related discipline.

• Over 7 years of experience in regulatory affairs with a strong emphasis on post-approval lifecycle management.

• Demonstrated experience in cross-functional global environments.

• Proven leadership experience in team management.

• Excellent strategic, communication, and stakeholder management capabilities.

🏝️ Benefits

• Medical

• Dental

• Vision

• Paid time off

• A 401(k) plan with opportunities for employee and company contributions

• Life insurance

• Disability

• Accident insurance

• Tuition reimbursement