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Our client is a development and commercialization service provider supporting the pharmaceutical and biopharmaceutical industries with drug development and bringing new drugs to market to improve human health. Their capabilities span from contract chemical process research and development to the supply of Active Pharmaceutical Ingredients (APIs) - as well as drug products for preclinical studies, clinical trials and commercial use.
They are currently looking for a Regulatory Affairs Manager at their location in the Basel area.
- Create and maintain registration dossiers for worldwide submissions
- Advise in regulatory compliance checks and be responsable for regulatory change management
- Work closely with development, quality control and analysis and production
- You provide regulatory support to our customers as part of process development during the clinical phases up to market launch
- Write Chemistry, Manufacturing and Controls (CMC) and New Drug Applications (NDA) dossiers
- Relevant working/residency permit or Swiss/EU-Citizenship required
- University education as a chemist / biochemist or pharmacist or a comparable degree
- Between 3 to 5 years of professional experience in the chemical-pharmaceutical industry, in Regulatory Affairs or Production or Quality Control
- Knolwedge of Active Pharmaceutical Ingredient (API) enviroment
- Good oral and written German and English skills