Director, Global Regulatory Affairs, Regulatory Strategy (Finance)

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, the regulatory leader will be primarily responsible for the development of global (and US) regulatory strategies (depending on the assigned project/projects) to advance Genmab's portfolio of development pipeline candidate drugs. This individual will provide strategic input and ensure operational execution of global (and US) submission activities. The individual will be responsible to interface directly with the global health authorities (and 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.

Responsibilities

Reporting to the Team Lead of Regulatory Strategy, Global Regulatory Affairs, the key responsibilities 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 (in line with Target Product Profile).

• 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 will involve collaboration with a partner.

• Evaluate regulatory risk and recommend mitigation strategies to ensure optimal regulatory success.

• 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

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

• Participate in the development of and assess the appropriateness of submission documentation to support successful IND/CTAs as well as BLAs/MAAs.

• Evaluate various regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, breakthrough therapy designation, PRIME, Fast Track, accelerated/conditional approval, compassionate use, pediatric plans) and ensure that they are implemented, if applicable

• Collaborate with the Labeling Team Lead to develop Company Core Data Sheet and US Prescribing Information depending on the role for the assigned product

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

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

• Monitor and assess global and US regulatory guidelines and regulations and current regulatory environment/landscape and their impact on the development of Genmab products

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

• 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 3-5 years of hands on industry experience within Regulatory Affairs (Oncology experience preferred)

• Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA)

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

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

• Strong strategic skills including the ability to make complex decisions and willingness to support difficult positions

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

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

• Ability to work well within cross-functional teams

• Strong communication skills - both oral and written

• Ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans

• Ability to influence others and resolve conflicts

• Cultural awareness and respect for diversity

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

Additional Job Description

• Develop and execute sound and robust Global Regulatory strategies for drug products at various stages of development

• Provide direction and guidance to project development team and drive regulatory activities to ensure likelihood of regulatory approvals

• Proactively evaluate and communicate regulatory risks and challenges and relevant mitigatory actions, to senior leadership and project teams

• Prepare/oversee/review/maintain regulatory documentation (e.g. regulatory sections of clinical applications, marketing applications, Health Authority briefings; agency request responses) as applicable, in markets within scope

• Drive compliance by providing guidance and advice to cross-functional teams on market legislation and other regulatory requirements as applicable

• Liaise and collaborate with internal teams (e.g. QA, manufacturing), external teams (e.g. contract manufacturing, CRO, affiliates), and regulatory & health authorities, in relation to matters of regulatory importance within scope

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

$190,720.00---$286,080.00

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 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.