Medical and Regulatory Affairs
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
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. life-cycle) 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
We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues.
We pursue disruptive and bold solutions for patients
We move together with speed and quality because patients are waiting
Our dedication to learning and excellence helps us to deliver exceptional results
We all own BMS’ success and strive to be transparent and deliver on our commitments
We embrace diversity and foster an environment where we can all work together at our full potential.
- 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.
- Strong scientific/medical background.
- Understanding of pharmaceutical product development
- Understanding of European regulatory principles and their impact on company’s 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.
- Optimal position to learn and understand the perspectives of key stakeholders (both internal: R&D, Marketing, Legal, etc…and 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.
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.