Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change
Global Regulatory Strategist
Role responsibilities:
Define, drive, and monitor global regulatory science and priorities related to anticancer drug development
Support Regulatory Affairs Oncology and development by maintaining and communicating timely regulatory information and outcomes of research that may inform global regulatory strategy, target label and cancer drug development
Monitor and analyze regulatory information, including precedence and evolving trends and guidance from major Health Authorities regarding anticancer drug regulatory decision making, e.g. precision oncology, advanced therapies to inform regulatory strategy
Draft and disseminate relevant internal communication, including regular Oncology Regulatory Newsletter
Provide input on global draft Oncology guidance documents and position papers by facilitating discussion among internal Bayer experts/stakeholders to support final Bayer Oncology position
Potential to be a representative in relevant trade associations organizations or initiatives outside of Bayer related to regulatory science/innovation
Role requirements:
Bachelor of Science with at least 10 years of experience in biomedical activities of which at least 5 years including local / global regulatory experience, or Master of Science with at least 8 years of experience in biomedical activities of which at least 3 years including local / global regulatory experience, or Ph.D. or D.V.M. or Pharm. D. in Life Sciences with at least 6 years of direct experience in biomedical research, of which at least 1 year includes local/global regulatory experience
Robust knowledge in anticancer drug development and related global regulatory requirements
Experience in a regulatory science area preferred, knowledgeable in uses of Real-World Data in drug development and/or patient engagement
High degree of judgment and insight regarding regulatory issues
Strong strategic thinker with an ability to carry through an initiative and/or project to completion.
Strong analytical skills and communication skills (verbal and written)
Strong expertise in researching and summarizing findings in a clear and concise manner
An open, inclusive and global mindset able to bring innovative solutions
Comfort level with IT tools for researching regulatory precedence and industry trends
Location:
Switzerland : Basel-City : Basel
Division:
Pharmaceuticals
Reference Code:
428782