Bristol Myers Squibb International Strategy Lead Oncology in Princeton, New Jersey
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Support I-O Intercontinental portfolio with Regulatory strategy for each asset, including new trials, marketing authorization, HA interactions, and support.
•Scope : Products (DP4.5 to DP8 and beyond, including initial submissions, major variations) – BMS Footprint except US, EU, Japan, China, Canada
•Advise and support Local GRS for assessing regulatory landscape and regulations
•Provide actionable Regulatory Input into Development Strategy
•Advise global team on specific local requirements or gaps in clinical program
•Champion for countries to obtain needed global and regional resources
•Strategize with GRT Lead and other core GRT members on the regulatory strategy for NCEs and major variations
•Interface between Global and Local, the ISLs lead International Regulatory Teams
•ISLs Co lead with GRTLs the development and execution of the Global Regulatory Engagement Plan
•Transversal activities : Represent GRS international on R&D (FDT/EDT/LCM/MLT/IDT) teams on an ad hoc basis to communicate and advocate regional regulatory strategies and plans when agenda is relevant to the international markets
•Primary interface, ISLs collaborate and partner with other International counterparts
•International support for alliances ISLs participate in external partnership negotiations, execution and and implementations
•Represent GRS and/or GRS International on specific non-product related projects when ISL role input is required
•Regulatory Experience in Local, Regional or Global group (Country Head, GRM, EUL, USL, country regulatory manager, etc.) or R&D experience in drug development (GDO, RCO, etc.)
•Experience in Oncology Therapeutic area is preferred
•Experience with understanding and advising regulatory strategies in coordination with clinical plans and marketing objectives.
•Ability to represent GRS functions on project team.
•Experience with understanding multiple local country environments and regulations
•Ability to translate local regulatory requirement in global action plan
•Experience with communicating regulatory strategy, issues, and risks in written and verbal format to multiple BMS stakeholders (Commercial, Medical, Market access …)
•Experience coordinating communications within teams and across functions.
•Experience applying project management techniques within teams.
•Experience in effectively managing meetings and driving plans while functioning remotely.
•Demonstrated ability to break down complex, scientific content into logical components.
•Demonstrated ability to facilitate issue resolution.
•Demonstrated ability to organize / prioritize tasks.
•Understanding of tactical role of GRS in the drug development process.
•Understanding of general global regulatory requirements for drugs in development.
•Understanding of PD&C process and specific GRS responsibilities / deliverables at PD&C Decision Points for International
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled