Specialist Administration & Support (m/f/x) Regulatory Affairs

Daiichi Sankyo Europe GmbH

Job Description

With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life.

In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.

Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.

For our headquarter in Munich we are seeking highly qualified candidates to fill the position:

Specialist Administration & Support Regulatory Affairs (m/f/x) - Part-time; 20 hours per week


Provide administrative support to the Head of EU & International Regulatory Affairs and their team members, support budgeting, procurement and contracting processes, individual training files and the organization of internal and external team meetings.

Roles and Responsibilities:

  • Provide general administrative organizational support to the Regulatory Affairs department. Travel Management for senior members of the department
  • Creation and follow up of expense claims for senior team members
  • Organization of internal and external meetings, as directed
  • Manage office and ensure timely provision of office material and technical service of office equipment
  • Act as training supervisor and administrative assistant for the creation and maintenance of the individual training files as described in the relevant SOP, maintain training curricula and the list of initials
  • Plan and process the annual review of training files
  • Organize the onboarding of new team members and external contractors including request of user accounts and technical equipment, as needed
  • Support planning budgeting, procurement and contracting processes in accordance with the company procedures. Support budget forecast
  • Support the preparation of contracts with contractors and service providers. Communicate with vendors ensuring correct invoicing procedures
  • Initiate purchase orders, assign invoices to an account and initiate the approval of invoices in SAP and DokuWeb
  • Maintain oversight of budget and financial project status and tracking and monitor purchase orders and invoices
  • Agree and regularly book accruals based on progress
  • Act as organizational back up for the provision of GMP and CPP certificates

  • Educational degree as office clerk, translator, lab/ technical assistant or equivalent
  • Experience in office management and supporting a team
  • Working experience in pharmaceutical industry, in a Regulatory Consultancy or Clinical Research Organization is preferred
  • Team oriented and forward-thinking attitude, strong interpersonal and communication skills, structural and independently way to work, talent for organization, ability to prioritize, computer proficiency (e. g. MS office, document management
  • systems, databases, SAP), written and verbal communication skills in English and German, third language preferred


  • Excellent Benefits
  • Work-Life Balance
  • Growth and Development
  • Health and Wellbeing Support
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