Director, Regulatory Affairs Strategy

Princeton, NJ, United States

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 experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization. In this role, you will be primarily responsible for the development of global and US regulatory strategies to advance Genmab's portfolio of development pipeline candidate drugs. You will provide strategic input and ensure operational execution of global and US submission activities. You will be responsible for interfacing directly with the US FDA as the primary contact for the company for assigned programs.

This position is based in our Princeton, NJ office which requires onsite presence 60% of the time per our hybrid policy. This position will report to the Regulatory Strategy Team Lead.

Responsibilities:

The key responsibilities of this role will include, but are 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 at various stages of development (in line with Product Development Plan).

Represent GRA in Compound Development Teams (CDT) to successfully meet project deliverables while adhering to regulatory requirements for programs and products. Lead the Global Regulatory Team (GRT) and Submission Team(s). Participate in Clinical Trial Teams, as required for the assigned project(s).

For approved products, ensure that regulatory strategies throughout life-cycle management are in place and implemented including label improvement, health authority meetings, potential ROW submissions, supplemental BLA submissions, tracking of progress of PMRs and PMCs, etc. This responsibility may involve collaboration with a partner.

Evaluate regulatory risk and recommend mitigation strategies to the cross-functional teams and management.

Lead the strategic development of briefing materials and prepare teams for US/global health authority meetings.

Participate in the development and review of submission documentation to support successful INDs/CTAs as well as marketing applications (e.g., BLAs/MAAs).

Evaluate competitive landscape and various regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, breakthrough therapy designation, Fast Track, accelerated approval, pediatric plans) and present options and recommendations to expedite the path to market, as applicable.

Collaborate with the Labeling team to develop the Company Core Data Sheet and US Prescribing Information depending on the assigned project(s).

Consult with senior management to develop and communicate regulatory strategies and advice for products and programs.

Interact with the US FDA and global health agencies for assigned project(s). The US/GRL will lead and/or participate in meetings with FDA and other health authorities as appropriate.

Monitor and assess regulatory guidelines, 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 ways of working.

Build strong relationships with key external stakeholders including regulatory agencies, professional societies, and key opinion leaders, as relevant.

Participate in review of and comment on regulatory guidance as relevant.

As assigned by management, provide regulatory due diligence assessment of licensing/acquisition opportunities.

Requirements: BSc or MSc level degree preferably within the life sciences (PharmD, PhD preferred)

Minimum of 5-8 years of hands-on industry experience within Regulatory Affairs (Oncology and/or immunology and inflammation is preferred)

Prior experience of direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA)

A solid understanding and experience in drug development including early and late development is highly preferred.

A broad knowledge of life-cycle management is highly preferred.

Strong strategic skills including the ability to make complex decisions

Solid knowledge and understanding of global and US regulations and the US pharmaceutical market

Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance

Strong organizational, communication (both oral and written), and time management skills needed to manage multiple ongoing projects/tasks 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.

Ability to influence others and resolve conflicts

Highly motivated and self-driven individual who enjoys being challenged.

Unquestionable ethics, professional integrity, and personal values consistent with the Genmab values

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

$170,625.00$284,375.00

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.

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 https://www.genmab.com/privacy.

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.