Associate Director, Global Regulatory Science
vor 3 Wochen
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.
***
**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.
-
Associate Director, Global Regulatory Science
vor 3 Wochen
Boudry, Schweiz Bristol Myers Squibb Vollzeit**Working with Us** Challenging. 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...
-
Associate Director, Global Regulatory Strategy
vor 3 Wochen
Boudry, Schweiz Bristol Myers Squibb Vollzeit**Working with Us** Challenging. 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...
-
Associate Director, Global Regulatory Strategy
vor 2 Wochen
Boudry, Schweiz Bristol Myers Squibb Vollzeit**Working with Us** Challenging. 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...
-
Associate Director Global Regulatory Sciences
vor 2 Wochen
Boudry District, Schweiz Bristol Myers Squibb VollzeitWorking 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...
-
Associate Director, Global Regulatory Strategy
vor 2 Wochen
Boudry District, Schweiz Bristol Myers Squibb VollzeitWorking 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...
-
Director, Global Regulatory Lead
Vor 6 Tagen
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. 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...
-
Market Access/heor Gbds Associate Director
vor 3 Wochen
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. 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...
-
Market Access/heor Gbds Associate Director
vor 3 Wochen
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. 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...
-
Associate Director Global Digital Transportation
Vor 6 Tagen
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. 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...
-
Director, Global Regulatory Lead
vor 2 Wochen
Boudry District, Schweiz Bristol-Myers Squibb VollzeitWorking 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...
-
Director, Global Regulatory Lead
vor 1 Monat
Boudry, Schweiz Bristol Myers Squibb VollzeitWorking with Us Challenging. 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...
-
Director, Global Regulatory Lead
vor 4 Wochen
Boudry, Schweiz Bristol Myers Squibb VollzeitWorking with Us Challenging. 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...
-
Director, Global Apheresis Operations
Vor 6 Tagen
Boudry, Schweiz Bristol Myers Squibb Vollzeit**Working with Us** Challenging. 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...
-
Director, Global Regulatory Lead
vor 2 Wochen
Boudry District, Schweiz Bristol Myers Squibb VollzeitWorking with Us Challenging. 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...
-
Associate Director, Strategic Partnerships
vor 2 Wochen
Boudry District, Schweiz Bristol Myers Squibb VollzeitAt 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...
-
Market Access/HEOR GBDS Associate Director
vor 4 Wochen
Boudry, Schweiz Bristol-Myers Squibb VollzeitMarket Access/HEOR GBDS Associate Director page is loaded Market Access/HEOR GBDS Associate Director Apply locations Boudry - CH time type Full time posted on Posted 5 Days Ago job requisition id R1581394 Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But...
-
Associate Director, Operations Portfolio Lead
vor 2 Monaten
Boudry, Schweiz Bristol Myers Squibb Vollzeit**Working with Us** Challenging. 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...
-
Scientific Associate Director Drug Product
vor 4 Wochen
Boudry, Schweiz Hobson Prior Vollzeit**Salary**: CHF100 - CHF115 per hour**Job type**: Interim/Contract **Location**: Boudry, Schweiz **Function**: Technical Operations, Quality Control, Chemist **Posted**:11/05/2023 **Ref**: BBBH22278 - Hi I'm Christopher , I manage this role Hobson Prior are currently seeking for a Scientific Associate Director Drug Product Pharmaceutical Development...
-
Associate Director, Drug Development Project
vor 3 Wochen
Boudry, Schweiz Bristol Myers Squibb Vollzeit**Working with Us** Challenging. 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...
-
Associate Director, Quality Product Lead
vor 2 Wochen
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. 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...
