Senior Regulatory Affairs Manager

Job Summary

Seeking an experienced Senior Regulatory Affairs Manager, this full-time remote position will manage clinical and nonclinical regulatory functions, serve as the Global Regulatory Lead, and oversee the preparation and submission of regulatory filings.

Key responsibilities

• Serve as Global Regulatory Lead (GRL) and develop regulatory strategy, including global interactions
• Lead the preparation and submission of regulatory filings such as INDs, CTAs, and marketing applications
• Collaborate with cross-functional teams to communicate regulatory strategies and manage Health Authority interactions

Required qualifications

• Bachelor's degree or higher
• 5 or more years of hands-on regulatory experience, preferably in oncology
• Demonstrable record of leadership and teamwork in a cross-functional environment
• Experience with radiopharmaceutical therapy is a plus
• Strong understanding of the regulatory landscape and relevant disease areas