Regulatory Affairs Project Lead
10 hours ago
Company Overview
Genmab is an international biotechnology company with a passion for transforming the lives of patients through innovative and differentiated antibody therapeutics.
With a core purpose guiding its unstoppable team, Genmab strives towards improving the lives of patients by inventing next-generation antibody technology platforms and leveraging translational research and data sciences.
The company has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies to develop and deliver novel antibody therapies to patients.
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.
Job Description
We are seeking a highly motivated Regulatory Affairs Project Lead to join our Global Regulatory Affairs organization in Copenhagen, Denmark.
As a key member of our team, you will be responsible for representing RA in the Clinical Trial Teams and ensuring regulatory oversight and progress of multiple clinical trial submission activities.
You will work closely with the CRO and internal stakeholders to ensure an optimal EU/ROW regulatory strategy for the compound.
Key Responsibilities:
- Represent RA in the Clinical Trial Teams and ensure oversight and progress of multiple, often highly complex, clinical trial submission activities.
- Represent EU/ROW in the Global Regulatory Team(s).
- Act as EU/ROW regulatory lead for the assigned project(s) and be responsible for the development and execution of the EU/ROW strategy.
- Lead the preparation of strategic regulatory documents, e.g., Briefing Packages, ODDs, PIPs, etc.
- Plan, prepare and lead EMA or 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 preferred.
- Minimum of 8 years of experience in Regulatory Affairs, preferably in development phase.
- Experience in proactively planning and executing highly complex clinical submission strategies.
- A good understanding of drug development and EU regulatory procedures. Experience within oncology will be a plus.
- Prior experience leading health authority meetings with the EMA or other health authorities. Experience with PIPs will be a plus.
- Strong project management skills.
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.
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