As one of the world’s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day
Please join us as
CTD Manager (m/f)
The Common Technical Document (CTD) Manager as a member of the Regulatory Affairs Department, is responsible for writing the medicinal substance and medicinal product related documentation for Clinical Trial and Marketing Applications of drug-device combination products and for answering to technical requests from the Health Authorities.
Your ResponsibilitiesYour Profile
- 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 and Analytical Quality Control
- Prepare answers to the questions raised by the Health Authorities following the submission of Clinical Trial Applications in collaboration with the Regulatory Affairs Manager
- Ensure consistency between raw data and registration documents contents
- Support Regulatory Affairs Manager in evaluating the regulatory impact of changes as well as the investigations and documentation needed before implementing and preparing the new submission documents
- University degree in Pharmacy, Chemistry, Biology or comparable education
- Experience in a similar position within a pharmaceutical or combination device company
- 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 submission of drugs and/or combination devices and associated regulatory assessment of variation/changes
- Proficiency in english language is required, good german is an asset
Are you interested? Please apply online! We are looking forward to welcoming you.
Working hours: Vollzeit
Type of contract: Unbefristet
Job ID: 4001
Contact: Bianca Wisner
Tel.: +41 44 864 5107
We do not accept applications from Headhunters.