Head of EU Regulatory Affairs Oncology

Head of EU Regulatory Affairs Oncology

Daiichi Sankyo Europe

Munich, Germany

Key responsibilities:

  • Develops and implements the strategy for EU Regulatory Affairs Oncology, serves as the subject matter expert in European Regulatory strategy for Oncology across the portfolio;
  • Accountable for the creation of robust CE Portfolio European regulatory strategies and tactics;
  • Serve as Strategic EU regulatory lead for key early stage ADCs;
  • Responsible for implementing and overseeing strategy, activities and compliance to achieve successful submissions and approvals in the Europe;
  • Leads the European strategic planning and establishment of CE project European regulatory goals;
  • Manages internal and external relationships and acts as a lead representative with European regulatory authorities;
  • Continuously builds European team capability through high quality talent selection, mentoring and providing feedback, coaching, and professional development.

Profile:

  • Master Degree or PHD in chemistry, biology, pharmacy or other related discipline or equivalent;
  • Min. 15 years relevant professional experience in the pharmaceutical industry (min. 7 years in regulatory affairs);
  • Substantial late stage Oncology submission and approval experience in Europe;
  • Min. 7 year leadership experience in an international environment;
  • Documented ability to network and engage with senior oncology regulatory officials in Europe;
  • Thorough understanding of oncology drug development (MAAs/CTAs) through market launch;
  • Proven ability to lead, inspire, develop, coach and influence a team of direct and indirect reports in Regulatory Affairs;
  • Demonstrated (matrix) leadership skills;
  • Strategic and analytical abilities, diplomacy, negotiation and excellent oral and written communications skills;
  • Business Fluent in English.

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© EuroJobsites 2019

EuroJobsites is a UK 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

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