Director of Regulatory Affairs

Job Summary

A company is looking for a Director in Regulatory Affairs - CMC.

Key Responsibilities

• Develop and execute global regulatory strategy for radiopharmaceutical drugs, ensuring successful IND, CTA, DMF, NDA, and MAA submissions
• Oversee the content development and compliance of regulatory documentation for submission to global Health Authorities
• Manage multiple complex projects and maintain strong relationships with cross-functional teams to align deliverables with regulatory strategy

Required Qualifications

• Bachelor's degree in chemistry or related field, or a Master's degree with 7+ years of regulatory experience, or an advanced degree with 5+ years of regulatory experience
• Experience with radiopharmaceutical therapy and independently authoring regulatory filings (IND, IMPD, NDA, MAA, DMF) is required
• Understanding of phase-appropriate data requirements for regulatory filings is desired
• Demonstrated leadership and teamwork in a cross-functional industry environment
• Proficiency with regulatory documentation and compliance standards