In this newly created position, the Regulatory Labeling (Associate) Director will be responsible for leading the development and maintenance of global labeling documents (e.g., Target Label, Core Data Sheet, USPI, EU SmPC and related patient information) for the Genmab portfolio of products. In this blended role, the 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 Senior Director, Labeling and Intelligence. The position will be based in our Princeton, New Jersey site. 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.
- Provide leadership in development of target labeling documents to support the design and analysis plan for clinical trials.
- 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 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; 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.
- Providing disease area specific regulatory intelligence, interpretation, and impact analysis of emerging external competitive landscape.
- Contribute to Global Regulatory Affairs (GRA) by providing novel insight that will inform the regulatory strategy for the drug development projects.
- Communicate the regulatory impact and implications of relevant competitive intelligence to stakeholders and senior management at Genmab.
- Prepares the submission-ready labeling documents; Maintains and tracks labeling documents in the electronic system as appropriate.
- Participates in the development and maintenance of SOPs, work instructions, templates, and associated documents
- Bachelor’s degree in a scientific discipline is required, with PharmD/PhD/MD preferred.
- 6+ years of pharmaceutical industry experience, including 4 years Labeling (preferred) or regulatory intelligence experience
- In-depth knowledge of current US and global regulations and guidance as they relate to overall global labeling
- Understanding of clinical development of novel biologics products, preferably in immune-oncology area
- Experience developing and managing labeling content for at least one major US submission (NDA/BLA), through negotiations and approval preferred
- Familiar with end-to-end labeling processes
- 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.
- 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. Experience leading 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.
- Strong sensitivity for a multicultural/multinational environment
- Proficiency with MS-Office Suite and Adobe Acrobat application and ability to work in electronic document management system