Director, Global Regulatory Europe
Bristol Myers SquibbNeuchâtel 2
Date de publication:04 juin 2022
Type de contrat:Durée indéterminée
Director, Global Regulatory Europe
At 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 every treatment we pioneer. Join us and make a difference.
We are currently recruiting for a Director, Global Regulatory Science-Europe (Immunoscience, fibrosis, Cardiovascular, and Neuroscience therapeutic areas)
Supervision of ERLs (European Regulatorily leads) responsible for assigned therapeutic areas. This covers the following activities:
- Integrates the European regulatory, legal, scientific/medical and business perspectives to achieve the optimal regulatory outcomes in accordance with company objectives
- Translates strategy into operational goals and objectives, identifies resources and leads to organization to focus on objectives
- Assures that organization follows through to achieve high quality execution of plans
- Contributes and adds value to the writing of scientific documents for regulatory purpose
- Executes negotiations with EMA in line with BMS strategy, provides strategic directions, and supervises negotiations with other relevant regulatory agencies for assigned project
- Provides direction for maximizing opportunities within projects (e.g. life cycle) and across the geographical area to support the productivity priorities
- Participates actively in and represents Global Regulatory Sciences for their project on various multifunctional 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 partners when applicable
- University degree in life sciences (PhD, PharmD, Msc, others) 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, behaviours, 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
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognises 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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. If you require reasonable adjustments in completing this application, or any part of the recruitment process direct your enquiries to Write an email. Applicants can request an approval of an adjustment prior to accepting a job offer.