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Director, Global Regulatory Sciences, Europe
View: 147
Update day: 18-03-2024
Location: Boudry Neuchâtel NE
Category: R & D IT - Software
Industry: Pharmaceutical Manufacturing
Position: Director
Job type: Full-time
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Job content
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 Sciences, Europe (immunoscience, fibrosis, cardiovascular, and euroscience therapeutic areas).Position ResponsibilitiesSupervision 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
- You will help patients in their fight against serious diseases
- You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
- You’ll get a competitive salary and a great benefits package
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Deadline: 02-05-2024
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