Senior Manager, Global Regulatory Affairs, Strategy

Role Summary

Senior Manager, Global Regulatory Affairs, Strategy. The role involves implementing US regulatory strategy for late-stage compounds, serving as Global Regulatory Lead for assigned projects, and providing regulatory expertise to cross-functional teams to ensure optimal regulatory strategies and timely submissions. Hybrid position based in Princeton, NJ, with remote work up to 40%.

Responsibilities

• Act as the US/Global Regulatory Leader (GRL) for assigned project(s) and develop, implement, and maintain US/global regulatory strategies.
• Lead the US regulatory submission strategy and maintain submission planning.
• Strategically develop briefing materials and prepare teams for global health authority meetings.
• Evaluate regulatory risk and recommend mitigation strategies to ensure regulatory success.
• Represent US regulatory affairs in Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and other cross-functional teams.
• Participate in developing submission documentation to support IND and (s)BLA submissions.
• Evaluate regulatory mechanisms (e.g., orphan/drug designation, Fast Track, accelerated approval) and implement as applicable.
• Plan, prepare, and lead FDA meetings in collaboration with Global Regulatory Lead.
• Support development of Company Core Data Sheet and US Prescribing Information.
• Maintain IND documentation.
• Monitor global and US regulatory guidelines and their impact on product development.
• Maintain up-to-date regulatory knowledge and contribute to regulatory processes and working instructions.

Qualifications

• Minimum of Bachelor's degree or equivalent in scientific discipline or health-related field.
• Minimum of 3‚Äì5 years of experience in Regulatory Affairs.
• Solid understanding and experience in oncology drug development.
• Strong project management skills.
• Prior experience interacting with FDA as sponsor contact person.
• Experience with first-wave BLA and/or sBLA submissions is highly preferred.
• Experience supporting multiple complex submissions and maintenance of regulatory documentation.
• Strong organizational, communication, and time management skills; attention to detail; ability to work independently and drive projects to successful outcomes; robust cross-functional teamwork; ability to build relationships; highly motivated and self-driven; ability to prioritize in a fast-paced environment; goal-oriented and committed to Genmab‚Äôs success.

Skills

• Regulatory strategy development
• Global health authority interactions
• IND/sBLA submission planning and execution
• Risk assessment and mitigation
• Cross-functional collaboration
• FDA engagement and sponsor communications

Education

• Bachelor‚Äôs degree or equivalent in a scientific or health-related field

Additional Requirements

• Hybrid work arrangement; eligible for remote work up to 40% of time