Bristol-Myers Squibb Company

Associate Director, International Regulatory Strategy Lead

Princeton, NJ, United States
May 26, 2019
Required Education
Bachelors Degree
Position Type
Full time
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.


Scope: Support products (including initial submissions, major variations) - BMS Footprint except US, EU, Japan, China, Canada

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 (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 (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


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