Associate Director, Global Regulatory Affairs, Strategy
Genmab
Plainsboro, NJ
9 days ago
$165,600 - $248,400
This Job Position Has Expired
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Job Description
Join Genmab as an Associate Director in Global Regulatory Affairs, where you'll lead regulatory strategies for innovative cancer treatments. Collaborate with cross-functional teams and act as a key contact with the FDA, driving impactful regulatory submissions and strategies that shape the future of oncology therapies.
Key Responsibilities
Act as US/Global Regulatory Leader for assigned projects
Develop and implement US/global regulatory strategies
Serve as FDA contact for assigned projects
Lead the strategic development of briefing materials
Evaluate regulatory risk and recommend mitigation strategies
Prepare for and lead FDA meetings as relevant
Maintain IND and monitor regulatory guidelines
Required Qualifications
Bachelor's degree in scientific discipline or health-related field
Minimum 5 years of experience in Regulatory Affairs
Strong project management skills
Experience interacting with FDA as sponsor contact
Preferred Qualifications
Experience managing first wave BLA and/or sBLA submissions
Experience in oncology drug development
Experience in supporting multiple complex submissions
Benefits & Perks
Health insurance401kPTOSupport for physical, financial, social, and emotional wellbeing