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Senior Regulatory Project Manager

vor 2 Monaten


Munich, Bayern, Deutschland Daiichi Sankyo Europe GmbH Vollzeit
About Daiichi Sankyo Europe GmbH

We are a leading pharmaceutical company with over 120 years of experience and a presence in over 20 countries. Our mission is to discover, develop, and deliver innovative treatments that improve the quality of life for patients worldwide.

Job Summary

We are seeking a highly skilled Senior Regulatory Project Manager to join our team in Munich, Germany. As a key member of our Regulatory Affairs department, you will be responsible for leading and coordinating complex regulatory projects and filings, ensuring compliance with technical and regulatory standards.

Key Responsibilities
  • Lead and coordinate regulatory projects and filings in the field of RACMC
  • Ensure compliance with all relevant technical and regulatory requirements
  • Collaborate with internal and external stakeholders to successfully implement regulatory projects, submissions until approval
  • Create and maintain regulatory project plans, schedules, and resources
  • Monitor project progress and report to Global RACMC management
  • Identify and manage regulatory project risks and issues
  • Conduct regular project meetings and provide updates to stakeholders
  • Develop and implement process improvements to enhance project efficiency
  • Participate or lead assigned non-project tasks and process improvements
  • Provide technical guidance and support to team members
Requirements
  • Master degree in Life Science or Pharmacy; Master Degree in Regulatory Affairs is a plus
  • Minimum of 5 years of experience in the pharmaceutical industry
  • Minimum of 3 years of experience in global regulatory affairs
  • Project Management knowledge and certification preferred
  • Proven ability to plan, coordinate and lead projects simultaneously on multiple projects
  • Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation
  • Experience of working in global environment in interdisciplinary teams
  • Experience of working in interdisciplinary teams
  • Solution and detail-oriented; well organised and self-motivated
  • Excellent written and oral communication skills in English, German as a second language preferred
  • Strong working knowledge of Microsoft Office
What We Offer
  • Excellent benefits
  • Work-Life Balance
  • Growth and Development
  • Health and Wellbeing Support