In this position, the Regulatory Intelligence (Associate) Director will be responsible for providing oncology specific regulatory intelligence, interpretation, and impact analysis of emerging external competitive landscape. To support the Labeling and Intelligence Team, the lead may also be responsible for leading the development and maintenance of assigned global labeling documents (e.g., Target Label, Core Data Sheet, USPI, EU SmPC and related patient information) for the Genmab portfolio of products.
This role will be within Global Regulatory Affairs (GRA) and will report to the Senior Director, Labeling and Intelligence. The position is based in our Princeton, New Jersey site. The level of the role will be commensurate with the individual's level of experience.
This position will serve as a Regulatory Intelligence expert:
- Provide disease area specific regulatory intelligence, interpretation, and impact analysis of emerging external competitive landscape.
- Monitor the regulatory environment including surveillance of changes in major health authority guidances and regulations, trends, and regulatory developments. Identify and assess impact to Genmab.
- Work closely with the global regulatory leaders (GRLs), regional regulatory leaders (RRLs) and global labeling lead (GLL) to provide the regulatory intelligence aspect of disease areas and product-specific regulatory strategies.
- 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
- Develop system for maintenance and dissemination of regulatory intelligence within Genmab
- Support identification or development of tools and resources to support the Regulatory Intelligence function
- Partner with internal intelligence functions across Genmab
To support the Labeling and Intelligence Team, this position may also:
- 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.
- 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
- Ensure that labeling documents are produced in a timely manner according to internal SOPs and external regulatory requirements.
- Bachelor’s degree in a scientific discipline is required, PharmD/PhD/MD preferred.
- 6+ years of pharmaceutical industry experience, including 4 years work related to intelligence or 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.
- Understanding of clinical development of novel biologics products, preferably in immune-oncology area
- Ability to think strategically, communicate risks, and recommend course of action
- Working knowledge of current US and global regulations and guidance as they relate to overall global labeling
- 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