Senior Manager, Global Regulatory Affairs, Strategy

Role Summary

Senior Manager, Global Regulatory Affairs, Strategy. Implement US regulatory strategy for late-stage compounds and/or serve as Global Regulatory Lead for assigned projects. Provide regulatory expertise to global and cross-functional teams to ensure optimal regulatory strategy and timely, high-quality submissions. Hybrid role based in Princeton, NJ, with remote work up to 40%.

Responsibilities

• Act as the US/Global Regulatory Leader (GRL) for assigned project(s) and be responsible for the development, implementation and maintenance of US/global regulatory strategies (in line with Target Product Profile).
• As the US Regulatory lead, be responsible for the implementation and maintenance of the US regulatory submission strategy.
• Lead the strategic development of briefing materials and prepare teams for global health authority meetings.
• Evaluate regulatory risk and recommend mitigation strategies to global regulatory lead to ensure optimal regulatory success.
• Represent US RA in the Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and other cross-functional teams as required for the assigned project(s).
• Participate in the development of and assess the appropriateness of submission documentation to support successful IND and (s)BLA submissions.
• Evaluate regulatory mechanisms that allow optimization of product development (e.g., orphan designation, breakthrough therapy designation, Fast Track, accelerated approval, pediatric plans) and ensure implementation if applicable.
• In collaboration with Global Regulatory Lead, plan, prepare and lead FDA meetings as relevant.
• Support global regulatory lead and labeling strategy lead in development of the Company Core Data Sheet and US Prescribing Information.
• Responsible for maintenance of the IND.
• Monitor and assess global and US regulatory guidelines and regulations and their impact on development of Genmab products.
• Maintain updated knowledge of regulatory topics and participate in maintaining regulatory processes and working instructions.

Qualifications

• Educational background: Bachelor’s degree or equivalent in scientific discipline or health-related field.
• Minimum 3–5 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 managing first wave BLA and/or sBLA submissions is highly preferred.
• Experience in supporting multiple complex submissions and regulatory documentation.
• Strong organizational, communication, and time management skills; detail-oriented; able to work independently; robust cross-functional teamwork; ability to build collaborative relationships; motivated and self-driven; able to prioritize in a fast-paced environment; goal-oriented.

Skills

• Regulatory strategy development
• Global health authority interactions
• IND/BLA/submission planning and execution
• FDA liaison and sponsor communications
• Cross-functional collaboration

Education

• Bachelor’s degree or equivalent in scientific discipline or health-related field

Additional Requirements

• Hybrid work arrangement with 40% remote work may be required
• Location: Princeton, NJ