Senior Manager, Global Regulatory Affairs, Strategy

GENMAB A/S • Princeton, NJ

158d • $128,640 - $192,960 • Hybrid

About The Position

At Genmab, we are dedicated to building extraordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so. Does this inspire you and feel like a fit? Then we would love to have you join us! Genmab is looking for a Senior Manager, Global Regulatory Affairs, Regulatory Strategy to be a part of our Global Regulatory Affairs organization. In this role, you will work in close collaboration with the Global Regulatory Lead on a compound in late-stage development to implement the US regulatory strategy for multiple new indications and/or serve as a Global Regulatory Lead for assigned projects. You will act provide regulatory expertise and guidance on global procedural and documentation requirements to the Global Regulatory Team and cross-functional teams to ensure an optimal regulatory strategy for the compounds. You must have strong project management capabilities and will be responsible for planning, coordinating, and executing timely and high-quality submissions to regulatory authorities.

Requirements

• A minimum of Bachelor's degree or equivalent in scientific discipline or health-related field.
• Minimum of 3-5 years of experience in Regulatory Affairs.
• A solid understanding and experience in oncology drug development is required.
• 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, maintenance of regulatory documentation, and other regulatory support activities.
• Strong organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously.
• Must have attention to detail and be able to solve problems with minimal supervision.
• Be able to work independently with an ability to drive projects to successful outcomes.
• Robust cross-functional teamwork skills and enjoy working in a global environment.
• Skills in building and maintaining internal and external collaborative relationships to achieve shared goals.
• Highly motivated and self-driven individual who enjoys being challenged.
• Able to prioritize your work in a fast paced and changing environment.
• Goal-oriented and committed to contributing to the overall success of Genmab.

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 and 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 various regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, pediatric plans) and ensure that they are implemented, 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 Sheep and US Prescribing Information.
• Responsible for maintenance of the IND.
• Monitor and assess global and US regulatory guidelines and regulations and current regulatory environment/landscape and their impact on the development of Genmab products.
• Maintain an updated knowledge of regulatory topics and regulations and participate in maintaining and preparing regulatory processes and working instructions.

Benefits

• 401(k) Plan: 100% match on the first 6% of contributions.
• Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance.
• Voluntary Plans: Critical illness, accident, and hospital indemnity insurance.
• Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave.
• Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support.
• Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees