Senior Manager Regulatory Affairs (m/f/d)


  • To represent the Regulatory Affairs Function in cross-functional global development teams and to provide regulatory guidance and strategy for assigned projects and products
  • To plan, lead and manage regulatory submissions during development and life cycle management for assigned products in Europe
  • Guide and coordinate regulatory submissions in non-European countries in close collaboration with the global development team and the regions
  • To act as regulatory contact person for authorities, external partners and in-house functions
  • To keep current with the regulatory and scientific environment and support the creation of Standard Operating Procedures
  • Bachelor degree in Life Science or Medical Science, Master or PhD preferred; Masters Degree in Regulatory Affairs is a plus
  • Post-doctorate or professional experience in pre-clinical or clinical trials is a plus
  • Minimum of 5 years experience in the pharmaceutical industry with 3-5 years direct regulatory affairs experience with emphasis on drug development and marketing authorization applications in Europe and other global markets
  • Experience with pediatric clinical development and/or interactions with PDCO is a plus


» Job description


Employer:
Daiichi Sankyo Europe GmbH
Location:
81379 Munich