Associate Director - Global Regulatory Sciences Europe > Boudry > Joboolo CH :
Company : Bristol Myers Squibb Location : Boudry Neuchâtel From : Neuvoo CH
Kommen Sie zu BristolMyersSquibb und machen Sie einen Unterschied.
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 ResponsibilitiesIntegrates 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 GlobalRegulatorySciences for their project on various multifunctional committees or teams.Communicates actively and timely with GlobalRegulatorySciences 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 RequirementsStrong scientific/medical background/university scientific degreeConducted 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 peersDemonstrated ability to react appropriately in difficult, possibly adverse, conditions and/or in crisis situationsDemonstrated ability to integrate regulatory, scientific/medical and business perspectives and to translate this analysis into practical recommendations and operational goalsDeveloped working relationships and/or built a team resulting in a performant network or organization Understanding of pharmaceutical product developmentUnderstanding of EU regulatory principles and their impact on company's development and businessUnderstanding of the complexities of cross functional management issues Understanding of legal and business aspects related to EU regulatory procedures and outcomesWir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen.
Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor.
BristolMyersSquibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld.
Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen. BristolMyersSquibb BoudryNeuchâtel
