Global Regulatory Sciences
In Global Regulatory Sciences, our overall goal is to get safe and effective medicines to patients faster.
We are the primary communication link between Bristol-Myers Squibb and worldwide regulatory agencies, such as the U.S. Food and Drug Administration. In addition, we serve as the primary communicator of the laws, regulations, guidelines and guidances from these regulatory agencies to the other members of the company’s research, development, manufacturing and commercial staff. As such, we interact with the vast majority of the other departments within the company.
Historically, we’ve supported the development and registration of medicines, and ensured that product information for regulatory agencies accurately reflects the benefits and the risks of our medicines, as well as how to use them appropriately.
We also play a role in helping our development teams generate the critical data to support our registration claims, and satisfy formulary requirements. Today we need to think about payers and insurance companies to give them the information they need to understand the benefit of our medicines for patients.
We have adopted the innovative approach of fostering face-to-face interaction between our development scientists and the critical regulatory scientists. Having this scientist-to-scientist interaction with the health authority early in a drug’s development has the potential to streamline the development process. When we are talking about patients with serious diseases and significant unmet medical need, scientists understand the sense of urgency and will reach a consensus in a much more collaborative way.
People come to work here because they’re listened to and they see an opportunity to influence the development process and bring new medicines to patients. “We treat each other with courtesy and respect, and we’re accountable for each other’s success,” says Dick Wolgemuth, Ph.D., senior vice president, Global Regulatory Sciences.
We seek to fill critical positions for physicians, biologists, chemists, Ph.D.s, and Pharm.D.s who display excellent scientific, clinical or pharmaceutical development knowledge. Credentials are expected, but so is personal integrity and passion.