The Role
& DepartmentAs an (Associate) Director, Global Regulatory Affairs Project Lead you will join our Global Regulatory Affairs organization. In this capacity, you will assume responsibility for the EU/ROW regulatory strategy, closely collaborating with the Global Regulatory Team on one or multiple compounds in early or late-stage development. The chosen candidate will act as the representative of RA on the Clinical Trial Teams, ensuring regulatory oversight of clinical trial submission activities. Additionally, they will serve as the primary contact with the EMA, offering regulatory expertise and guidance on EU/ROW procedural matters and documentation requirements to both the Global Regulatory Team and Compound Development Team. The ultimate goal is to ensure an optimal EU/ROW regulatory strategy for the compound. Furthermore, the position will report to the Global Regulatory Strategy Team Lead.
Key responsibilities include
Act as EU/ROW regulatory lead and EMA contact person for assigned project(s) and be responsible for the development and execution of the EU/ROW strategy
Represent RA in the Clinical Trial Teams and ensure oversight and progress of multiple, often highly complex, clinical trial submission activities
Evaluate competitive landscape and various regulatory mechanisms that allow optimization of product development and present options and recommendations to expedite the path to market in EU/ROW, as applicable
Lead the preparation of strategic regulatory documents, e.g. Briefing Packages, ODDs, PIPs, PRIME etc.
Plan, prepare and lead EU and national Scientific Advice procedures as relevant
Evaluate regulatory risks and recommend mitigation strategies to the cross-functional teams and management
Monitor and assess regulatory guidelines and regulations and current regulatory environment/landscape and their impact on the development of Genmab products
Maintain an updated knowledge of regulatory topics and regulations and participate in maintaining and preparing regulatory processes and ways of working
Requirements
A minimum of Bachelor’s degree or equivalent in scientific discipline or health-related field. Master’s degree will be preferred
Minimum of 7-8 years of experience in Regulatory Affairs, preferably in development phase
Significant experience in proactively planning and executing highly complex clinical submission strategies
A solid understanding of drug development and EU regulatory mechanisms to expedite development. Experience within oncology will be a plus
Prior experience leading health authority meetings with the EMA or other health authorities, as well as experience with PIPs
Strong project management skills
Moreover, you meet the following personal requirements:
Strong organizational, communication, and time management skills needed to manage multiple ongoing projects simultaneously
Must have attention to detail and be able to solve problems with minimal supervision
Be able to work independently with an ability to drive projects to successful outcomes
Robust cross-functional teamwork skills and enjoy working in a global environment
Skills in building and maintaining internal and external collaborative relationships to achieve shared goals
Highly motivated and self-driven individual who enjoys being challenged
Able to prioritize your work in a fast paced and changing environment
Goal-oriented and committed to contributing to the overall success of Genmab
This role is located in Copenhagen, Denmark and is hybrid.
About You
Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
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