Regulatory Affairs Manager (m/f)

REFERENZNUMMER:

237488/11

IHRE AUFGABEN:

-Preparation and submission of new Market Authorization Application (MAAs) in Switzerland, according to Swissmedic guidelines
-Submission and follow up of clinical trials/clinical trial amendments; requiring close monitoring if changes in regulatory environment (CCMO, CGR)
-Follow-up on regulatory product updates (variations), partnering with CROs in order to assure timely submission/implementation
-Prepare and implement new or changes to SOPs
-Supervision of quality/regulatory aspects of distribution in Switzerland; establish audit plans according to compliance needs; follow up on corrective action plans

IHRE QUALIFIKATIONEN:

-PhD or Masters in Pharmaceutical Sciences or equivalent (e.g. PhD or Master in Biomedical Sciences, Biochemistry, Biology)
-Solid experience in and understanding of regulatory affairs and regulatory requirements in pharmaceutical/biotech industry is required, especially on the Swiss market
-Insight in strategic aspects of clinical trial conduct in the pharmaceutical/biotech industry
-Experience in submitting clinical trial applications/amendments to the Swiss CCMO
-Good knowledge of written and spoken German and English, knowledge of French would be an asset
-Able to prepare regulatory submissions in line with international or regional requirements and scientific and company policies and procedures
-Ability to assess promotional materials for clearance of use in Switzerland
-Ability to handle routine labeling changes and drug listing
-Pay attention to detail and being highly accurate

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager