Associate Director - Global Regulatory Sciences Europe

☞ Bristol Myers Squibb

View: 153

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.Responsible for providing EU regulatory strategic support to global development programs and executing Health Authority negotiations in line with BMS strategy for assigned projects/therapeutic area.Position Responsibilities
  • 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 and 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.
  • Watches, anticipates and acts on trends and changes in the European and international regulatory environment which may have an impact on the business
Requirements
  • Strong scientific/medical background/university scientific degree
  • Conducted prior negotiations with (a) regulatory authority(ies)
  • Contributed to scientific documents developed for regulatory purposes 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 built a team resulting in a performant network or organization Understanding of pharmaceutical product development
  • Understanding of EU 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 EU 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 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.
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Deadline: 02-05-2024

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