Research Assistant Drug Approval (Manager Regulatory Affairs / Pharmacist) (m/f/d)

Regulatory care of the company's medicinal product authorisations and approvals, including the processing of new applications for authorisation and renewal, as well as amendments to the competent federal authority in coordination with the internal specialist departments Processing of applications and advertisements to local monitoring authorities to maintain the production permits of the pharmaceutical entrepreneur Monitoring regulatory requirements and legal developments in the field of medicine and implementation of relevant requirements in the company Coordination and timely submission of Periodic Safety Update Reports (PSUR) in coordination with the Stage Plan Officer Information of the cooperation partners/plasma collectors on the data of the plasma master file and maintenance of the corresponding documentation Establishing a process for regulatory auditing and management of contracts with cooperation partners

Successfully completed university studies of pharmacy or a comparable scientific discipline Interest in medicinal product issues as well as regulatory requirements in the field of pharmaceuticals and willingness to work into relevant legal requirements and regulatory processes Safe handling of current MS Office applications Independent, structured, careful and reliable operation Communication skills and team spirit

As an advanced employer, we attach great importance to effective processes, short decision-making and the further development of our employees. You can also benefit from many benefits such as occupational retirement and need-oriented health promotion. Your co-operation with the blood donation service also means long-term security for you, because our supply order is essential for the health system and regardless of economic fluctuations. .