Bristol Myers Squibb International Strategy Lead Innovative Medicines 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.
The ISLs lead International Regulatory Teams engaging the local GRS regulatory teams, communicating project specific information (follow-up, update) to local teams, ensuring alignment between registration/submission requirements and development plans, translating global regulatory expectations into local plans and leading the execution of these plans, digesting and communicating Global Regulatory plans, including HA engagement plans to countries, digesting and communicating results for key clinical trials, obtaining aligned regulatory position.
Represent and deliver the Global TA position, track the execution of the global submission plan. ISLs Co lead with GRTLs the development and execution of the Global Regulatory Engagement Plan. Represent GRS international on R&D development teams on an ad hoc basis to communicate and advocate regional regulatory strategies and plans when agenda is relevant to the international markets. As the primary interface, ISLs collaborate and partner with other International counterparts (Commercial, Medical, Access, HEOR, supply chain, TO) to obtain alignment with the regulatory strategies and submission plans (as applicable). Provide International support for alliances: ISLs participate in external partnership negotiations, execution and implementation, when applicable, to ensure advanced awareness of regulatory risks and seamless integration.
Bachelor's degree required/ Advanced degree preferred
At least 8 years of experience in the following: 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.) Ability to represent GRS functions on project team.
Experience with understanding and advising regulatory strategies in coordination with clinical plans and marketing objectives.
Experience with understanding local environment and regulation
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 working across time zones and cultures.
Experience in Immunoscience, Virology or Fibrosis Therapeutic area is preferred.
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.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.