\\n Working with Us Challenging. Meaningful. Life-changing. Those aren\\xe2\\x80\\x99t 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\\xe2\\x80\\x99ll 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:
Integrates the European regulatory, legal, scientific/medical and business perspectives to achieve the optimal regulatory outcomes for assigned project(s) in accordance with company objectives.
Translates strategy into operational goals and objectives, identifies resources and leads the organization to focus on objectives. Assures that organization follows through to achieve high quality execution of plans.
Ability to contribute and add value to the writing of scientific documents for regulatory purpose.
Able to act as Contact Person for assigned project(s) with EMA in line with BMS strategy and to provide strategic directions and supervise negotiations with other relevant regulatory agencies for assigned project.
Provides direction for maximizing opportunities within projects (eg. lifecycle) and across the geographical area to support the productivity priorities.
Participates actively in and represents GRS-EU for their project(s) in the Global Regulatory Team and on various multi-functional committees or teams.
Communicates actively and timely with Global Regulatory Sciences colleagues in European countries, including through direction of European Regulatory Teams.
Active participation in regional organizational activities for the Liaison function (across projects)
Develops strong working relationships with key stakeholders both within and outside the company.
Builds and maintains strong relationships with alliance partner when applicable.
Watches, anticipates and acts on trends and changes in the European and international regulatory environment which may impact on the business.
Core BMS Leadership Values
Integrity
We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.
Innovation
We pursue disruptive and bold solutions for patients
Urgency
We move together with speed and quality because patients are waiting
Passion
Our dedication to learning and excellence helps us to deliver exceptional results
Accountability
We all own BMS\\xe2\\x80\\x99 success and strive to be transparent and deliver on our commitments
Inclusion
We embrace diversity and foster an environment where we can all work together at our full potential.
Experiences Desired:
Experience in Oncology is required
Conducted prior negotiations with (a) regulatory authority(ies)
Contributed to scientific documents developed for regulatory purpose.
Established credibility and respect during previous exposure with regulatory authorities and peers
Demonstrated ability to react appropriately in difficult, possibly adverse, conditions and/or in crisis situations
Demonstrated ability to integrate regulatory, scientific/medical and business perspectives and to translate this analysis into practical recommendations and operational goals
Developed working relationships and/or build a team resulting in a performant network or organization
Demonstrated values, behaviors, professional standards and cultural sensitivity compatible with BMS vision and culture.
Knowledge Desired:
Strong scientific/medical background.
Understanding of pharmaceutical product development
Understanding of European regulatory principles and their impact on company\\xe2\\x80\\x99s development and business
Understanding of the complexities of cross functional management issues
Understanding of legal and business aspects related to European regulatory procedures and outcomes.
Compatible with BMS vision and culture.
Developmental Value:
Optimal position to learn and understand the perspectives of key stakeholders (both internal: R&D, Marketing, Legal, etc\\xe2\\x80\\xa6and external: regulatory and public health authorities, scientific community).
Gain increased understanding of company strategies, decision processes and implementation processes.
Learn to leverage personal impact by addressing complexity, setting priorities, translating strategies into operational goals and objectives, and exerting leadership to enhance organizational performance.
If you come across a role that intrigues you but doesn\\xe2\\x80\\x99t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as \\xe2\\x80\\x9cTransforming patients\\xe2\\x80\\x99 lives through science\\xe2\\x84\\xa2 \\xe2\\x80\\x9d, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.
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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.\\n \\n \\n \\n \\n \\n