EU/ROW Regulatory Lead and Project Manager
4 weeks ago
Genmab A/S is an international biotechnology company seeking a skilled EU/ROW Regulatory Lead and Project Manager to join our Global Regulatory Affairs organization.
About the RoleThis challenging position involves representing Regulatory Affairs in Clinical Trial Teams, ensuring oversight and progress of multiple clinical trial submission activities. The successful candidate will also represent EU/ROW in the Global Regulatory Team, lead the development and execution of the EU/ROW regulatory strategy for assigned projects, and plan, prepare, and lead EMA or national Scientific Advice procedures.
Key Responsibilities- Regulatory Leadership: Provide strategic guidance on EU/ROW regulatory matters, develop and execute regulatory strategies, and ensure compliance with relevant regulations and guidelines.
- Clinical Trials Management: Represent Regulatory Affairs in Clinical Trial Teams, oversee clinical trial submissions, and coordinate with internal stakeholders and CROs.
- Project Management: Manage multiple projects simultaneously, prioritize tasks, and meet deadlines while maintaining attention to detail and problem-solving skills.
- Collaboration and Communication: Work effectively with cross-functional teams, stakeholders, and external partners to achieve shared goals, and communicate complex information clearly and concisely.
- Educational Background: Bachelor's degree or equivalent in a scientific discipline or health-related field; Master's degree preferred.
- Experience: Minimum 8 years of experience in Regulatory Affairs, preferably in development phase up to and including submission of global marketing authorization applications.
- Skills and Qualifications: Strong project management skills, attention to detail, ability to work independently, and excellent communication and teamwork skills.
As a member of our team, you can expect a competitive salary of approximately $150,000 per year, plus benefits and opportunities for professional growth and development.
About Genmab A/SWe are an innovative biotechnology company dedicated to transforming the lives of people with cancer and other serious diseases through our pioneering antibody therapeutics. Our core purpose guides our unstoppable team as we strive towards improving the lives of patients worldwide.
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