Beschreibung
Director of Regulatory AffairsCompany
This is a strongly desired company to work for who specialize in developing innovative manufacturing processes and the production of pharmaceutical ingredients. With offices around the world, this position is based in their headquarters in the German region of Switzerland, an area that offers one of the highest standards of living across the world.
Position
In this position you will act as the lead for the newly created Regulatory Affairs department including two existing Regulatory groups. You will ensure the compilation of Regulatory dossiers for API`s as well as the filing and maintenance of the dossiers with Health Authorities worldwide. Furthermore, you must ensure the compliance of API`s. You will also act as the expert for regulatory questions and collaborate with internal and external stakeholders providing them with expert advice.
Qualifications
- Masters or PhD in Chemistry or Pharmacy
- At least 8 years of experience in Regulatory Affairs (Pharma)
- Strong knowledge of registration requirements for Pharmaceuticals (EU and US)
- Familiar with IMPD and CTD
- Experience with CMC
- Knowledge of eCTD
- Fluent in German and English
If you are interested in this opportunity or other Regulatory Affairs positions within Switzerland then feel free to get in touch with Matthew Lillywhite, specialist consultant in Regulatory Affairs for the Medical Device, Pharmaceutical and Biotech industries. You can contact me at on . I look forward to hearing from you.