Global Regulatory Affairs Project Manager
11 hours ago
At Genmab, we're dedicated to pushing the boundaries of cancer treatment and serious diseases. Our team of experts is committed to developing innovative antibody products that transform patients' lives.
The Role & Department
We're seeking an experienced Global Regulatory Affairs Project Lead to join our Global Regulatory Affairs organization. As a key member of our team, you'll play a crucial role in shaping our EU/ROW regulatory strategy and ensuring compliance with regulatory requirements. You'll work closely with the Global Regulatory Team on multiple compounds in early or late-stage development, acting as the primary contact with the EMA and providing regulatory expertise and guidance on EU/ROW procedural matters.
Key Responsibilities
- Develop and execute the EU/ROW regulatory strategy for assigned projects, ensuring alignment with company goals and objectives.
- Represent RA in Clinical Trial Teams and ensure oversight and progress of multiple clinical trial submission activities.
- Evaluate competitive landscape and regulatory mechanisms to optimize product development and present options for expedited market access.
- Prepare strategic regulatory documents, such as Briefing Packages, ODDs, PIPs, PRIME etc.
- Lead EU and national Scientific Advice procedures as relevant.
- Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management.
- Monitor and assess regulatory guidelines and regulations, maintaining an updated knowledge of regulatory topics and participating in maintaining 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 7-8 years of experience in Regulatory Affairs, preferably in development phase.
- Significant experience in proactively planning and executing complex clinical submission strategies.
- Solid understanding of drug development and EU regulatory mechanisms, with experience in oncology 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.
About Us
- We are a global biotechnology company committed to improving the lives of patients through innovative and differentiated antibody therapeutics.
- We have a passionate and collaborative team that invents next-generation antibody technology platforms and leverages translational research and data sciences.
- Our vision is to transform the lives of people with cancer and other serious diseases by 2030.
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