Description
We are looking for a
Regulatory Affairs Manager (m/f)
Reference: -en
Start: asap
Duration: 8 MM+
Place: in Basel
Branch: Herstellung von pharmazeutischen Grundstoffen
Your tasks:
- 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
Your qualifications
- 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
Skills:
- Regulatory affairs manager