Intercontinental Strategy Lead

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Scope

Products (GT5 to GT8 and beyond, including initial submissions, major variations) – BMS Footprint except US, EU, Japan, China, Canada, Switzerland

Summary

Advise and support Local GRS for assessing regulatory landscape and regulations to optimize our regulatory strategies and submission plans within and across a therapeutic area (TA) product portfolio

Provide actionable Regulatory Input into Development Strategy to enable timely commercial desirable registrations across the region.

Advise global team on specific local requirements or gaps in clinical program to support local submission and collaborate to develop mitigation plans (e.g. bridging/sub-population requirements)

Champion for countries to obtain needed global and regional resources (e.g., to participate in global trials, to prepare bridging reports, to respond to HA queries rapidly)

Strategize with GRT Lead and other core GRT members on the regulatory strategy for NCEs and major variations (e.g. line extensions, new indications, label enhancements) and to foster one regulatory voice

Interface between Global and Local, the ISLs lead International Regulatory Teams engage the local GRS regulatory teams, communicate Project specific information (follow-up, update) to local teams, ensure alignment between registration/submission requirements and development plans, translate global regulatory expectations into local plans and lead the execution of these plans, digest and communicate Global Regulatory plans, including HA engagement plans to countries, digest and communicate results for key clinical trials, obtain 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

Transversal activities : Represent GRS international on R&D (DT/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 (Commercial, Medical, Access, HEOR, supply chain, TO) to obtain alignment with the regulatory strategies and submission plans (as applicable)

International support for alliances ISLs participate in external partnership negotiations, execution and and implementations, when applicable, to ensure advanced awareness of regulatory risks and seamless integration

Represent GRS and/or GRS International on specific non-product related projects when ISL role input is required or when an opportunity arises

Requirements

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.

Key Requirements

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 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.

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.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com