Regulatory Affairs Manager - Oncology

Job Summary

To support the oncology portfolio, the full-time remote Regulatory Affairs Manager - Oncology will manage regulatory promotional strategies for approved and pipeline oncology products, ensuring compliance with FDA regulations and effective communication with healthcare professionals and the public.

Key responsibilities

• Provide strategic direction for product and disease communications, ensuring truthful and non-misleading messaging
• Serve as the regulatory advertising and promotion lead for oncology products, ensuring compliance with regulations and internal policies
• Identify opportunities and challenges impacting product strategy based on the evolving regulatory environment and clinical data

Required qualifications

• Doctorate degree, or Master's degree with 2 years of industry experience, or Bachelor's degree with 4 years of industry experience, or Associate's degree with 8 years of industry experience, or High school diploma/GED with 10 years of industry experience
• 2 years of experience in Oncology (preferred)
• Experience in interpreting government regulations, policies, and guidance
• Strong clinical data analysis skills
• Experience collaborating within large cross-functional teams