Cmc Quality

LimmaTech Biologics AG is a Swiss clinical stage biopharmaceutical company. We are advancing our proprietary vaccine pipeline to halt the increasing threat of global infections due to emerging antimicrobial resistance (AMR) and sexually transmitted diseases. Working at LimmaTech is a unique chance to be part of the development of life saving vaccines.

We are currently looking for a:
**CMC Quality & Regulatory Affairs Manager, 80-100%**

Your responsibilities will include:

- Co-developing the company’s regulatory strategy
- Selecting, qualifying, and managing CMC partners for quality and regulatory aspects
- Supporting the internal Quality Management System (QMS), including internal self-inspections
- Managing global CMC submission activities
- Co-authoring and managing regulatory CMC documentation in compliance with applicable regulations and internal procedures
- Initiating, maintaining, and leading Regulatory Authority correspondence and negotiations, setting objectives, and developing risk mitigation plans

You are an efficient and enthusiastic team player with:

- A university degree in life or pharmaceutical sciences
- Minimum of 3 years’ CMC experience in the biotech or pharmaceutical industry, with at least 2 years in Regulatory Affairs (preferably with different Regulatory Agencies), Quality, Pharmaceutical Development, Clinical Trial Applications, or other relevant areas
- Solid technical regulatory expertise. Experience in QbD, process and analytical validation, CMC-bridging strategies and with different regulatory authorities is a plus
- A positive, proactive, goal oriented can-do attitude
- Strong project management skills
- Excellent verbal and written communication skills in English

We offer a friendly, highly motivated, multi-cultural, and dynamic work environment located in Schlieren, near Zürich. The location is easily accessible by public transportation.

Please note that due to visa regulations, only applicants eligible to work in Switzerland can be considered for this position.