Global Regulatory Strategist
- Employer
- Bristol Myers Squibb Company
- Location
- Princeton, NJ, United States
- Start date
- Aug 9, 2019
View more
- Discipline
- Regulatory, Regulatory Affairs
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
Global Regulatory Strategist for antithrombotic assets will have leadership responsibility for global regulatory strategy within the Innovative Medicine portfolio. Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies. Co-lead marketing application submission teams for indications that are at regulatory filing stage to develop content strategy for global dossiers. Contribute in developing target labeling. Ensure consistent positions are presented in responses to global Health Authority (HA) queries. Ensure global development plans will meet global regulatory requirements by soliciting and integrating regional regulatory strategy liaison input. In collaboration with the Global Regulatory Subteam, develop global submission plans and HA interaction plans. Provide input into the development of protocol synopses and protocols. Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HAdeadlines.
Qualifications
PhD or MS in regulatory science with 4+ years in the pharmaceutical industry.
Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMD and across alliance.
Experience as a member of Global Regulatory Subteam, project working groups, or comparable experience.
Experience with developing regulatory strategiesin coordination with clinical plans and marketing objectives.
Experience with communication of regulatory strategy, issues, and risks in written and verbal format to MPD SLT and other governing bodies.
Experience utilizing leadership techniques to drive a team through the stages of teamdevelopment.
Experience coordinating communications within teams and across functions.
Experience applying project management techniques within teams. Experience in effectively managing meetings.
Demonstrated ability to breakdown complex, scientific content into logical components.
Demonstrated ability to coordinate global activities.
Demonstrated ability to facilitate issue resolution and conflict management.
Demonstrated ability to drive quality decision-making. Demonstrated ability to organize/prioritize tasks.
Demonstrated ability to negotiate with and influence others.
Understanding of strategic and tactical role for the antithrombotic drug development process.
Understanding of general global regulatory requirements for drugs in development.
Understanding of R&D process and specific regulatory responsibilities/deliverables for the company Decision Points
Company
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.
At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.
We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.
We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.
- Website
- http://www.bms.com/
- Phone
- +1-800-332-2056
- Location
-
430 E. 29th St
14th Floor
New York
New York
10016
United States
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