Sr Manager/Associate Director, Labeling, Policy, and Intelligence

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!

The Global Regulatory Labeling, Policy and Intelligence Sr Manager/Associate Director will be responsible for leading the development and maintenance of global labeling documents (e.g., Core Data Sheet, USPI, EU SmPC and related patient information) for the Genmab portfolio of products. The lead may also be responsible for supporting regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, Policy and Intelligence. The position may be based in our Princeton, New Jersey site (which requires onsite presence 60% of the time per our hybrid policy) or may be remote.

Responsibilities

• Lead the Labeling Working Group (LWG) to develop and maintain labeling documents  including Company Core Data Sheets (CCDS), Core Safety Information (CSI), United States Package Inserts (USPI), Summary of Product Characteristics (SmPC), and their associated Patient Labeling Documents.

• Serve as the labeling subject matter expert responsible for advising teams on global labeling strategies based on Genmab’s development programs, target product profile, and competitive labeling precedent.

• Act as Global Labeling Lead, supporting development, approval and maintenance of regional labeling (e.g., JPI)

• Manage new projects and projects of increased complexity including those involving 3rd party collaborators 

• Keep up to date with global labeling guidelines and regulations as they relate to the development/maintenance of labeling documents and advise the LWG accordingly

• Advise LWG on the content of labels in the same therapeutic class, competitor labeling and labeling trends, proposing content as relevant to support optimized labeling.  

• Ensure proper development, review, approval, implementation, maintenance, distribution and tracking of labeling documents according to internal SOPs and external regulatory requirements.

• Prepare submission-ready labeling documents; Maintain and track labeling documents in the electronic system as appropriate.

• Participate in the development and maintenance of SOPs, work instructions, templates, and associated documents

This position may also support regulatory policy and/or intelligence deliverables:

• Monitor the regulatory environment, including surveillance of changes in major health authority guidances and regulations, trends, and regulatory developments.  

• Manage process for dissemination of regulatory intelligence and subsequent impact assessment within Genmab

• Work closely with the global regulatory leads (GRLs), regional regulatory leads (RRLs) and global labeling leads (GLL) to support ad-hoc queries, providing novel insights to inform the regulatory strategies for development or marketed products.

• Support identification or development of tools and resources to support the Regulatory Intelligence function

• Support policy deliverables, e.g., call for comments efforts

Requirements

• Bachelor’s degree in a scientific discipline is required; PharmD/PhD preferred.

• 3-5 years of pharmaceutical industry experience preferred, including 2-3 years Labeling (preferred) or related experience

• In-depth knowledge of current US and global regulations and guidance, especially as they relate to global labeling

• Understanding of clinical development of novel biologics products, preferably in oncology

• Experience developing and managing labeling content for at least one major submission (e.g., NDA/BLA), through negotiations and approval preferred

• Familiar with end-to-end labeling processes

• Able to evaluate the impact of key Regulatory Intelligence on disease area and project strategy

• Ability to critically distinguish between “noise” and meaningful news to key stakeholders and senior leaders

• Ability to think strategically, communicate risks, and recommend course of action

• Self-starter with superior time management skills, ability to balance multiple tasks to meet priorities and timelines

• Ability to work independently or in teams. Ability to lead broad range of stakeholders at all levels internal and external to the company

• Strong attention to detail

• Effective communication skills, specifically excellent oral and written presentation skills.

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

• You are genuinely passionate about our purpose

• You bring precision and excellence to all that you do

• You believe in our rooted-in-science approach to problem-solving

• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

• You take pride in enabling the best work of others on the team

• You can 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 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 Genmab.com and follow us on LinkedIn and X.

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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.