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Associate Director, Global Regulatory Science
vor 1 Monat
Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu Innovationen bei, die bedeutende Veränderungen vorantreiben. Wir verleihen jeder Therapie, für die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb und machen Sie einen Unterschied.
**Position Responsibilities**
- Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests, digital health and other devices to enhance the value of our pharmaceutical products across therapeutic areas
- Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies.
- 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 sub-team, 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 HA deadlines.
- Contribute in the developing of target labeling.
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**Degree / Experience Requirements**
- Bachelor’s degree required; advanced scientific degree preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the industry with at least 4+ years of US Regulatory Affairs experience
**Key Competencies**
- Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance. Experience utilizing leadership techniques to drive a team through the stages of team development.
- Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives.
- Experience as a member of Global Regulatory sub-team, project working groups, or comparable experience in the industry. Experience coordinating communications within teams and across functions.
- Experience with communication of regulatory strategy, issues, and risks in written and verbal format to governing bodies.
- Demonstrated ability to breakdown complex, scientific content into logical components.
- Ability to coordinate global activities, facilitate issue resolution and conflict management.
- Demonstrated ability to drive quality decision-making and ability to organize/prioritize tasks.
- Demonstrated ability to negotiate with and influence others.
- Understanding of strategic and tactical role for the 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.
Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor.
Bristol Myers Squibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen.
