Director Global Regulatory Affairs Regulatory Strategy

At Genmab were committed to building extranotordinary futures together by developing antibody products and pioneering knockyoursocksoff therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring candid and impactdriven 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 Genmabs portfolio of development pipeline candidate . This individual will provide strategic input and ensure operational 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 lifecycle 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 subteam 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 35 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 lifecycle 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 crossfunctional 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 crossfunctional 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:

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 rootedinscience approach to problemsolving
• 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 fastgrowing 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 worklife balance. Our offices are designed as open communitybased spaces that work to connect employees while being immersed in our stateoftheart laboratories. Whether youre 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 nextgeneration antibody technology platforms and leveraged translational research and data sciences which has resulted in a proprietary pipeline including bispecific Tcell engagers nextgeneration immune checkpoint modulators effector function enhanced antibodies and antibodydrug conjugates. To help develop and deliver novel antibody therapies to patients Genmab has formed 20 strategic partnerships with biotechnology and pharmaceutical companies. By 2030 Genmabs vision is to transform the lives of people with cancer and other serious diseases with KnockYourSocksOff (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).

Please note that if you are applying for a position in the Netherlands Genmabs policy for all permanently budgeted hires in NL is initially to offer a fixedterm 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 fixedterm employment contract.