Associate Director, Global Regulatory Affairs, Regulatory Strategy

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role

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(s) on a compound in late-stage development to implement the US regulatory strategy for multiple new indications. You will act as contact person with FDA and provide regulatory expertise and guidance on US procedural and documentation requirements to the Global Regulatory Team and cross-functional teams to ensure an optimal US regulatory submission strategy for the compound. You must have strong project management capabilities and will be responsible for planning, coordinating, and executing timely and high-quality submissions to the FDA.

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 US regulatory lead and FDA contact person for assigned project(s) and be responsible for the implementation and maintenance of the US regulatory submission strategy

·         For approved products, ensure that regulatory strategies throughout life-cycle management are in place and implemented including label improvement, health authority meetings, supplemental BLA submissions, tracking of progress of PMRs and PMCs, etc.

·         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

Requirements

·         A minimum of Bachelor's degree or equivalent in scientific discipline or health-related field.

·         Minimum of 5 years of experience in Regulatory Affairs.

·         A solid understanding and experience in oncology drug development is highly preferred.

·         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

Moreover, you meet the following personal requirements:

·         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

Additional Job Description

·         Manage multiple complex regulatory submission projects and drive execution of global plan through collaboration with team members and vendors

·         Track progress of key process components for own area (e.g. dossier submissions) through engagement with responsible cross-functional teams

·         Propose systemic actions to ensure efficient, effective, and compliant submissions in line with the overall strategy

·         Drive compliance with regulatory guidelines through prompt communication with relevant teams and conduct periodic review of all documents and dossiers as applicable

·         Proactively guide cross-functional teams as a subject matter expert to support submission strategy

For US based candidates, the proposed salary band for this position is as follows:

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.

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed 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 guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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 locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. 

Our commitment to diversity, equity, and inclusion

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website. 

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.