• Lead US regulatory intelligence acquisition, analysis, communication, and knowledge management
• Interpret and apply US regulatory intelligence to inform strategic decisions
• Manage and improve the GRIP CoE Hub
• Develop and implement an assigned project portfolio
• Lead DS regulatory policy and advocacy activities for assigned topics

Requirements

Bachelor's degree in medicine, life sciences, health, or related field required
7 or more years' experience in biopharma Regulatory Affairs
At least 3 years developing regulatory strategies
4 or more years leading Regulatory Intelligence & Policy activities in the U.S.
Strong relationships across FDA and PhRMA highly desirable
1 or more years experience working with international teams
1 or more years experience of working with oncology drugs, Biologics/ADCs Companion diagnostics preferred

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Hard Skills

regulatory intelligence
regulatory strategies
regulatory policy
project management
biopharma
oncology drugs
biologics
ADCs
companion diagnostics

Soft Skills

leadership
communication
relationship management
strategic decision-making
collaboration

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