Associate Director - Global Regulatory Sciences Europe

Associate Director - Global Regulatory Sciences Europe

BMS - Bristol-Myers Squibb

Boudry, Switzerland

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.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Switzerland     Clinical Research     Manager and Executive     Regulatory Affairs     BMS - Bristol-Myers Squibb    

© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies