Aufgaben

- Responsible for writing CMC Module 3 dossier for combination product development
- Preparing answers for questions raised by different Health Authorities (e.g. EU, USA, Australia, Canada, Japan)
- Creating the required summaries for specific submissions in collaboration with other departments
- Contact with external suppliers
- Manage the regulatory assessment and the submission of drug-related changes

Qualifikationen

- University degree in Pharmacy, Chemistry, Biology or comparable
- At least 2-3 years of relevant experience in the medical device industry, preferably working with combination products
- Excellent knowledge of applicable regulations (e.g.: ICH/GCP)
- Proficient in English, good German skills are of advantage