Manager Regulatory affairs

Contact name: Jack Watterson-Burnell

Contact email: jack@medella.life
Job ref: 560
Published: about 1 year ago
Regulatory Affairs Manager 

I am currently working with a Phenomenal Global Pharmaceutical company based in Germany who are seeking a RA manager to join them onsite at their location in Frankfurt.

This is an excellent opportunity for a motivated individual to join a highly successful and growing Pharma.


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: organisation 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

Your profile
 
  • 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 organisational skills and the ability to work in a team round off your profile