Associate Director, Global Regulatory Affairs, Strategy

Associate Director, Global Regulatory Affairs, Strategy

At Genmab, we are dedicated to building extra[not]ordinary 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 an Associate Director, 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 as a contact person with FDA and 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.

This is a hybrid position based in our Princeton, NJ office, and can work remotely 40% of the time. You will report to the Global Regulatory Strategy Team Lead.

Responsibilities

The responsibilities of the role will include, but is not limited to :

• 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, serve as the FDA contact person for assigned project(s) 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).
• Represent GRA in global Compound Development Teams (CDT) to successfully meet project deliverables while adhering to regulatory requirements for programs and products. Participate in regulatory sub-team, clinical management team, and labeling working group meetings, as required for the assigned projects
• 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

Requirements

Additional Job Description

For US based candidates, the proposed salary band for this position is as follows : $165,600.00 $248,400.00 The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.

Regular full-time U.S. employees are eligible to enroll in Genmab benefits. Our benefits package is crafted to help employees feel supported and cared for in all aspects of life physical, financial, social, and emotional.

About You

Locations

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you're in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genm