Intercontinental Regulatory Strategy Lead (Associate Director)

POSTED ON 10/15/2020 AVAILABLE BEFORE 8/17/2021
new Hired Organization Address Princeton, NJ Full Time

Job Posting for Intercontinental Regulatory Strategy Lead (Associate Director) at new

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Summary

Advise and support local Global Regulatory Sciences (GRS) for assessing regulatory landscape and regulations to optimize our regulatory strategies and submission plans within and across therapeutic area (TA) product portfolios.

Responsibilities:

  • 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 Global Regulatory Team (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 Regulatory Teams, engaging with regulatory teams, communicating project specific information (follow-up, updates) 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.
  • Communicate Global Regulatory plans, including HA engagement to countries, digest and communicate results for key clinical trials, and obtain aligned regulatory position.
  • Represent and deliver the Global TA position and track the execution of the global submission plan. 
  • Serve as the ISLs Co-lead with GRT Leads in 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.
  • As needed, serve 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.
  • International support for alliances ISLs participate in external partnership negotiations, execution 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

  • Scientific background with a minimum of a Bachelor’s degree (PhD, MD, PharmD, Masters, desired) and 5+ years of relevant experience in Regulatory Affairs.

  • 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 with understanding and advising regulatory strategies in coordination with clinical plans and marketing objectives.
  • Ability to represent Global Regulatory Sciences (GRS) functions on project teams.
  • 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.
  • Effectively manage meetings and drive plans while functioning remotely.
  • Experience applying project management techniques within teams.
  • Experience in Oncology Therapeutic area is preferred

Key Requirements

  • Demonstrated ability to break down complex, scientific content into logical components.
  • Understanding of tactical role of Global Regulatory Sciences (GRS) in the drug development process.
  • Demonstrated ability to organize / prioritize tasks and facilitate issue resolution.
  • Understanding of general global regulatory requirements for drugs in development.
  • Understanding of Product Development and Commercialization (PD&C) process and specific GRS responsibilities / deliverables at PD&C Decision Points for International.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

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