Bristol Myers Squibb Associate Director, Global Regulatory Strategy, Oncology in Princeton, New Jersey
Title: Associate Director, Global Regulatory Strategy, Oncology
Job Number: 1703735
GlobalRegulatory Strategy Lead (GRTL) will have leadership responsibility forimplementing the global regulatory strategy to support the development anddelivery of diagnostic tests to enhance the value of our pharmaceuticalproducts across therapeutic areas.
Provideregulatory support and guidance to Diagnostic Partners, Global RegulatoryLeads (GRTLs), development teams and/or project drug/diagnostic subteamson the regulatory strategy and execution of the integrated drug /diagnostic development plan.
Ensureglobal regulatory plans support a precision medicine approach (ieintegrated drug/diagnostic regulatory and submission plans), including HAengagement plans and mitigation strategies.
Supportthe preparation of health authority documents and governance presentationscontaining precision medicine plans.
Proposeinnovative approaches to resolve complex regulatory issues and increasespeed to patients.
Providestrategic input on key development documents, clinical protocols, studyreports, IBs, INDs, CTAs, IDEs, SRDs and PMAs.
Advancedtechnical degree, e.g., PhD, MD, PharmD, M.S. is preferred
8years of related experience
Experiencein successfully leading teams
Experienceworking with external partners
Demonstratedmatrix leadership skills and the ability to work effectively acrossmultiple disciplines internal and external to the organization.
Strongunderstanding of the drug development process and global regulatoryrequirements for drugs in development
Understandingof science in oncology and impact on the regulatory process
Prior experience with SRDs, IDEs, and PMAs and experiencedeveloping companion diagnostics is highly desired
Bristol-Myers Squibb is an equal opportunity employer - Minorities/Females/Protected Veterans/Disabled
Job: Med Reg Affairs