Global Regulatory, Safety & Biometrics
The work of R&D is highly regulated. The jurisdiction of health authorities governs clinical trial permissions, new drug applications, product information and labeling, drug safety reporting, manufacturing practices and other activities. This oversight continues after a product is approved and available to patients.
Global Regulatory, Safety & Biometrics (GRSB) is the primary communication link between Bristol-Myers Squibb and regulatory agencies worldwide. In addition, we serve as the primary communicator of the regulations, guidelines and guidances from these regulatory agencies to the other members of the company’s research, development, manufacturing and commercial staff.
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 also need to think about payers and insurance companies to give them the information they need to understand the benefit of our medicines for patients.
Our interactions with health authorities are guided by the principles of transparency, open communication and trust. We foster direct interaction between our development scientists, critical regulatory scientists and health authority scientists, working collaboratively towards the shared goals of protecting patient safety and addressing unmet medical needs.
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. At Bristol-Myers Squibb, we treat each other with courtesy and respect, and we’re accountable for each other’s success.
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.