Beschreibung
Areas of responsibility:- Preparation of new regulatory dossiers (DMF, CEP, CMC) for API and intermediates in the international field with focus on FDA, European Authorities andJapan
- Maintenance of dossiers based on changes and advice on the type of changes for the active pharmaceutical substance
- Answering questions to authorities and customers
- Coordination with internal positions involved in dossier preparation
- Review of customer CMC files
Recruitments:
- Degree (BSc/MSc or PHD) in chemistry or an equivalent area
- Practical experience in QA regulatory affairs
- Experience in the chemical API industry desirable
- Understanding of eCTD formats / requirements
- Knowledge of specific regulatory requirements from different regulatory bodies e.g. Japan
- Team- and process-oriented person, capable of working independently
- Sound knowledge of English and good understanding of German
More Details:
- 7 Months with theOpportunityfor an Extension
- Location:North Switzerland
- 50 %- 60 % onsite with option of a home office
- Start date: a.s.a.p.
For a confidential discussion about regulatory affairs projects in Switzerland, or to apply, then send your CV to or call me.
I am a specialist recruitment consultant in regulatory affairs for the Pharmaceutical & Biotechnology industry. I offer a number of search options within the industry with a special focus on Switzerland.
If you are a Pharmaceutical professional looking for your next opportunity, then please don't hesitate to get in contact with me. Alternatively if you are currently looking for skilled individuals for the development of your organisation, then I can certainly help.
Your personal contact:
Kristina Bröckel
Regulatory Affairs Consultant
Tel:
mailto:
To find out more about Real please visit www.realstaffing.com