Senior Director, Regulatory Affairs, Radiopharma

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

📋 Description

• Develop, manage, and implement global regulatory strategies for designated development initiatives and marketed products in the US and other key markets, supported by regional regulatory teams.

• Act as the primary regulatory representative in dealings with major health authorities, including the FDA, leading critical negotiations and ensuring the delivery of high-quality briefing packages and responses.

• Collaborate with R&D, CMC, Manufacturing, Clinical, Medical, Quality, Commercial, and Supply Chain teams to incorporate regulatory needs into global product strategies, development plans, and readiness for launch.

• Lead, guide, and nurture a global team of regulatory professionals across various regions.

• Ensure compliance globally throughout development, submissions, registration maintenance, and post-market activities.

• Assist in due diligence efforts for partnerships, acquisitions, and in-licensing opportunities by evaluating regulatory risks, pathways, and development strategies.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or a related field; an advanced degree is highly preferred.

• Over 12 years of experience in global regulatory affairs, including leadership roles with increasing levels of responsibility.

• Demonstrated experience navigating US FDA requirements, regulations, and pathways, including but not limited to Fast Track, Orphan Designation, Priority, and Rolling Review.

• Strong proficiency in Clinical and CMC regulatory strategy, with practical experience guiding Clinical and CMC teams through development, registration, and global change management.

• Proven ability to manage and develop regulatory teams across multiple regions.

• Comprehensive understanding of global regulatory frameworks from IND/CTA through marketing approval, post-approval changes, compliance, and pharmacovigilance-related requirements.

🏝️ Benefits

• Medical, dental, and vision coverage

• Paid time off

• 401(k) plan with employee and company contribution opportunities

• Life insurance

• Disability insurance

• Accident insurance

• Tuition reimbursement