Associate Director, Global Regulatory Strategy
vor 2 Wochen
**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 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.
**Responsibilities**
- Leadership responsibility for global regulatory strategy within the Hematology portfolio.
- Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global filing strategies.
- 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 HA deadlines.
**Qualifications**
- Solid scientific background (PhD, MD, Pharm.D., BS 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 BMS and across alliance.
- Experience as a member of Global Regulatory Subteam, project working groups, or comparable experience.
- Experience with developing regulatory strategies in coordination with clinical plans and marketing objectives.
- Experience with communication of regulatory strategy, issues, and risks in written and verbal format to governing bodies.
- Experience utilizing leadership techniques to drive a team through the stages of team development.
- Experience coordinating communications within teams and across functions.
- 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
- 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 the resources to pursue their goals, both at work and in their personal lives.
- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
**Uniquely Interesting Work, Life-changing Careers**
**On-site Protocol**
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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