CMC (Chemistry, Manufacturing, and Controls) Manager
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 by its global workforce. 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.
BIOTRONIK AG, Vascular Intervention (VI), in the Swiss town of Bülach, Zürich, develops and manufactures guide wires, stents and balloon catheters for the treatment of cardiovascular and endovascular diseases.
The CMC (Chemistry, Manufacturing, and Controls) Manager as a member of the Regulatory Affairs Department will be responsible for regulatory support for new and change projects, supporting the approval process, creating drug quality-related documents for CE marking submissions and worldwide registrations.
- 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
- 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
If you are interested in this versatile and challenging activity and would like to become part of our Regulatory Affairs Department team, please apply online. We look forward to talking to you!
Location: Bülach, Zürich | Working hours: Vollzeit | Type of contract: Unbefristet
Apply now: www.biotronik.com/careers
Job ID: 41785 | Contact: Pascal Jud
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.
Only direct applications will be considered for this vacancy. We do not accept speculative CVs or candidate profiles.