Our client, a Global Biotech Company, is seeking a Regulatory Affairs Strategy professional at either the Associate Director or Director level. This role will advise on North America regulatory strategies to maintain market access for products to support corporate goals within the Oncology space. The position will report directly into the VP of Regulatory Affairs Strategy. The company is growing exponentially with a focus in drug development within the oncology space; they have doubled in size in the US in the past 3 years.
This role is fully remote.
Responsibilities:
Work with other leaders in the business and act as a lead for a fast-paced program coming into Phase III.
Initially be an individual contributor but tasked with hiring at least one direct report.
Develop briefing books and act as main point of contact for FDA interactions.
Provide regulatory strategic direction for North America.
Qualifications:
8+ years of Regulatory Affairs Strategy experience
Oncology experience preferred but not required.
Must have developed briefing books and have significant experience working with FDA