RA Manager - Project Management

Posted 19 January 2023
LocationFrankfurt (Oder)
Job type Permanent
Contact NameDavid Skinner

Job description

Regulatory Affairs Manager - Project Management


Strengthen our motivated team in the area of ??Global Regulatory Affairs and grow with exciting challenges. As Regulatory Affairs Manager you will strengthen our Foundational Products Team, which is responsible for a broad range of products. Your area of ??responsibility includes the following activities:
  • Coordination and control of the implementation of change control procedures as well as analysis of the timely processing and implementation of changes
  • Taking over the project management within the framework of the commissioning of regulatory CROs: organization of tenders as well as cooperation in the preparation of the offer and the selection process
  • Creation and renewal of contracts with CROs and external partners
  • Carrying out compliance checks and monitoring the budget
  • Analysis of data on the performance of ECCs using suitable tools to record the implementation status and KPI fulfilment and their control

  • Completed scientific studies, preferably pharmacy, chemistry or biology
  • Several years of professional experience in the field of project management or approval of medicinal products
  • Knowledge of the processes in the regulatory environment and the requirements of the LCM activities are desirable
  • Very good knowledge of German and English, another foreign language is an advantage
  • Experienced handling of MS Office applications
  • An analytical and structured way of working with a strong understanding of numbers
  • Very good organizational skills and the ability to work in a team round off your profile

  • Permanent employment with long-term career opportunities
  • Flexible working time model that enables a good work-life balance
  • Attractive location with good transport links and modern workplaces
  • Global family business with flat hierarchies and short decision-making processes
  • Cooperation in multifunctional, international teams
  • Attractive remuneration with extensive social benefits