Regulatory Affairs Manager - Pharmaceutical Licensing | Regulatory Affairs Managerin - Arzneimittelzulassungswesen (m/w/d) in Teilzeit
PSE GmbH
Job Summary
As a Regulatory Affairs Manager at PSE GmbH, you will play a critical role in managing pharmaceutical licensing and compliance for a specialized consultancy. Your day-to-day responsibilities include handling IFA notifications, PZN management, and database research on licensing topics. You will oversee the implementation of the Falsified Medicines Directive, manage alerts, and review product information texts such as mock-ups and artwork. A significant portion of the role involves life-cycle management, coordinating national and international licensing procedures (variations, renewals), and maintaining direct communication with German authorities like BfArM and IFA. This part-time position (20-30 hours) is ideal for professionals seeking a family-friendly environment with modern workplace flexibility. You will act as a key contact for clients, providing regulatory scenarios and ensuring high-quality standards in accordance with Good Distribution Practice (GDP). The role offers a permanent contract and a collaborative, family-like atmosphere within an established team.
Required Skills
Education
Completed degree in natural sciences, equivalent advanced training, or relevant professional experience in the field.
Experience
- Professional experience in the field of Regulatory Affairs within the pharmaceutical industry
- Experience in managing national and international licensing procedures, including variations and renewals
- Experience in communicating with regulatory authorities such as IFA and BfArM
- Experience in checking product information texts, mock-ups, and artwork
Languages
Additional
- This is a part-time position (20 to 30 hours per week). Candidates must be able to communicate transparently with clients and demonstrate an acquisition-oriented mindset. Applications must be submitted exclusively as PDF files.