Aufgaben

- Act as a team member responsible for CMC related aspects in combination product development projects
- Write and update the Modules "Quality Overall Summary" and "Quality" of the CTD in collaboration with the units responsible for Formulation, Pharmaceutical and Process development, Production engineering and Analytical Quality Control
- Generate other modules of the CTD or summaries as required for specific submissions in collaboration with the applicable Biotronik Groups and Departments
- Prepare answers to the questions raised by the Health Authorities and Notified Bodies following the submission of Clinical Trial Applications or CE marking submissions in collaboration with the Regulatory Affairs Manager
- Prepare answers to the questions raised by authorities for high effort registration countries (e.g. USA, Australia, Canada, Japan) related to the medical substance
- Ensure consistency between raw data and registration documents contents
- Interact with external suppliers of drug substances and excipients
- Manage the regulatory assessment and the submission of drug-related changes to combination products and other changes

Qualifikationen

- University degree in Pharmacy, Chemistry, Biology or comparable education
- At least 2-3 years of experience in a similar position in the pharmaceutical industry or in medical device industry working with combination products
- Excellent knowledge of the applicable regulations and ICH Guidelines
- Documented training and experience in writing and updating the relevant sections of the CTD
- Experience with the submission of drugs and/or combination devices and associated regulatory assessment of variation/changes
- Proficiency in the English language is required, good German is an asset