Director, Regulatory Affairs - Immunology, Neuroscience, Fibrosis
Company: Bristol Myers Squibb
Location: Cambridge
Posted on: March 15, 2023
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Job Description:
Working with UsChallenging. Meaningful. Life-changing. Those
aren't words that are usually associated with a job. But working at
Bristol Myers Squibb is anything but usual. Here, uniquely
interesting work happens every day, in every department. From
optimizing a production line to the latest breakthroughs in cell
therapy, this is work that transforms the lives of patients, and
the careers of those who do it. You'll get the chance to grow and
thrive through opportunities uncommon in scale and scope, alongside
high-achieving teams rich in diversity. Take your career farther
than you thought possible.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. Read more:
Expected Areas of Competence--- Develop and lead Global and US
Regulatory activities for a Development Team (s), leveraging
primarily external resources for operation activities, and internal
resources for strategic and HA engagement.--- Collaborate and
influence internal BMS expertise and external regulatory resources
to assure regulatory issues are addressed in development plans---
Provide leadership to resolve critical regulatory project issues,
bring the appropriate regualtory experts together as needed---
Establish sound regulatory advice/position on key development
issues, and communicate same to DTL and other team stakeholders---
Develop registration strategy for a product, and translate that
into operational deliverables for execution by external and
specific internal resources--- Develop alternative plans for
achieving regulatory objectives with associated risks and
mitigation strategies--- Provide strategic regulatory input to key
development documents and study reports, including Clinical
protocols, clinical reports/summary documents, nonclinical
reports/summary documents Nonclinical and clinical summary
documents, Analysis Plans and DMC Charters--- Provide strategic
regulatory input on the target product profile, CCDS, and
country-specific label--- Create an asset specific Global and US
-HA interactions strategy, integrating regional/local objectives
and strategies and lead effective interactions with HA globally,
partner with regional / local liaisons to execute interactions---
Formulate US regulatory strategy and filings--- Formulate
integrated global submission plan for simultaneous filings and take
accountability for translating that into operational plans to be
delivered by external vendors--- Approval of regulatory
documents--- Ensure documents and regulatory dossier are compiled
according to appropriate standard and guidelinesBehaviors---
Translates broad strategies into specific objectives and action
plans that can be effectively executed by external partners.---
Sets challenging, but regulatory achievable objectives, comfortable
taking risk in the regulatory setting--- Generates alternative
regulatory strategies and plans, and assesses benefits and
risks.--- Develops contingency plans and meets challenges necessary
to execute business and action plans. Ensures these plans are
feasible using external resources.--- Creates a unified and
seamless team using both internal and external resources to execute
regulatory strategy--- Communicates opinions, facts and thoughts
with clarity, transparency and honesty--- Seeks multiple
perspectives and listens openly to others' points of views.---
Enables and demonstrates the courage to speak up on issues and
risks as well as on the good news.--- Demonstrates ownership of
results within (and beyond) area of responsibility.--- Sets clear
and high expectations and holds self and others accountable for
decisions and results achieved.--- Develops and applies unique
ideas and new methods to achieve higher performance and
excellence.--- Works across organizational, functional and
geographic boundaries to achieve company goals.--- Creates an
environment that encourages continuous improvement, innovation and
appropriate risk taking.--- Demonstrates resilience and
perseverance. -Degree / Experience Requirements
Keywords: Bristol Myers Squibb, Cambridge , Director, Regulatory Affairs - Immunology, Neuroscience, Fibrosis, Healthcare , Cambridge, Massachusetts
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