(Senior) Director, Global Regulatory Labeling & Intelligence
Location: Princeton, New Jersey
Type: Full Time
Required Education: 4 Year Degree
Internal Number: R2431
In this newly created position, the Global Regulatory Labeling and Intelligence Team Lead will be responsible for the design and execution of global labeling strategies and guidance to core labeling documents, including Company Core Data Sheet (CCDS), local labels, and product labels for the Genmab portfolio of products. The team lead will also be responsible for providing oncology specific regulatory intelligence, interpretation, and impact analysis of emerging external competitive landscape. This role will be within Global Regulatory Affairs (GRA) and will report to the Vice President, Head of GRA. The position can be based in our Princeton, New Jersey or Copenhagen, Denmark sites.
The level of the role will be commensurate with the individual's level of experience.
Serve as the labeling subject matter expert responsible for advising Compound Development Teams (CDTs) and management on global labeling strategies based on Genmab’s development programs, target product profile, and labeling and competitive precedence.
Guide 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 (SPC) for products registered in the EU, and their associated Patient Labeling Documents.
Keep up to date with labeling guidelines and regulations as they relate to the development/maintenance of labeling documents and advise the LWG accordingly, assess impact on Genmab development programs.
Advise LWG on the content of other labels in the same therapeutic class, including competitor labeling, to help the team in developing labeling text; monitor industry labeling trends and propose actions as appropriate
Lead LWG throughout the entire process, from the decision to create or update a labeling document (CDS/USPI/SPC) through notification to stakeholders to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements.
Ensure proper review, approval, implementation, maintenance, distribution and tracking of global labeling documents, including product labels, Target Product/Label Profile, CCDS for all Genmab products
Integrate overall business objectives into departmental labeling goals and standardize /develop labeling SOPs and processes utilizing industry labeling best practices
Providing disease area specific regulatory intelligence, interpretation, and impact analysis of emerging external competitive landscape.
Make significant contribution to Global Regulatory Affairs (GRA) by providing novel insight that will inform the regulatory strategy for the drug development projects.
be responsible for communicating the regulatory impact and implications of relevant competitive intelligence to stakeholders and senior management at Genmab
Work closely with the global regulatory leaders (GRLs) and regional regulatory leaders (RRLs) to provide the regulatory intelligence aspect of disease areas and product-specific regulatory strategies.
A minimum of a Bachelor’s Degree required; advanced degree preferred.
10+ years of pharmaceutical industry experience, including 5+ years of labeling and/or regulatory intelligence experience or a comparable discipline.
Demonstrated understanding of clinical development of novel biologics products, preferably in immuno-oncology area.
Strong understanding of scientific principles relevant to drug development and product labeling
In depth knowledge of current US and global regulations and guidance essential as they relate to overall global labeling
Ability 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
Have a working knowledge about Regulatory Intelligence Tools and stay current with Regulatory news regarding key competitors and the disease area.
Demonstrated ability to develop collaborative relationships to facilitate the accomplishment of work goals.
Demonstrated ability to use appropriate interpersonal styles and techniques to develop internal networks and lead negotiations with internal and external stakeholders.
Effective communication skills, specifically excellent oral and written presentation skills.
Ability to work well within cross-functional globally oriented teams.
Excellent organization and operational skills including planning, organizing and ability to motivate and lead others.
Ability to work in electronic document management systems, e.g. Veeva vault
Genmab is an international biotechnology company with a core purpose to improve the lives of people with cancer. For more than 20 years, Genmab’s vision to transform cancer treatment has driven its passionate, innovative and collaborative teams to invent next-generation antibody technology platforms and leverage translational research and data sciences, fueling multiple differentiated cancer treatments that make an impact on people’s lives. To develop and deliver novel therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. Genmab’s proprietary pipeline includes bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com and follow us on Twitter.com/Genmab.