Drug Regulatory Affairs Coordinator - Contract

REGULATORY AFFAIRS

- Gain and maintain access to the market of medicinal products:
- Coordinate and submit Marketing Authorization, license renewal, Product transfers and variation applications to Swissmedic. Collaborate with the Regulatory Affairs team
- Generate and submit Periodic Safety Update Reports (PSURs/PBRERs) to Swissmedic
- Create and revise (safety) labeling material/product information of medicinal products in collaboration with Marketing, Corporate, and the RA team
- Coordinate, prepare and submit Clinical Trial Applications (including notification of changes) to Swissmedic and Ethics Committees
- Maintain project/variation tracking lists and/or tools, and generate reports of submission activities
- Maintain oversight and accuracy of registered information of each medicinal product. Keep public database of SPC/PI and internal product lists up-to-date with registered product/labeling information
- Provide responses to medical/safety/quality requests from various stakeholders; interrelate with respective Business Units and Medical Information
- Review and approve promotional material, according to national and Corporate requirements as well as to approved product information
- Establish and revise documents of Regulatory Affairs processes in the Quality Management System, and conduct local training
- Comply with national regulations and guidelines, legal, regulatory, quality (eg, ISO, GxP) requirements and company policies; ensure high ethical conduct

We welcome applications of consultants' who match most of the above requirements and are available on a short notice. There is a competitive hourly rate available for the contract; alternative market rates are also welcome.

We hope the role will be of interest to you and understand that further information may be required before making an application to the end client, please feel free to send either your full name, contact details or a complete CV via this website and I will endeavour to get back to you with further information on the role and answer any questions you may have.

Key Words: Regulatory Affairs, Labelling, Marketing authorization applications, Clinical Trial applications, Complaints handling, German, Contract, Switzerland

Kind regards

Pira Jeya

Michael Bailey Associates

Job code: 111663

Michael Bailey International is acting as an Employment Business in relation to this vacancy.