CMC quality & regulatory affairs manager, 80-100%

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.

As member of the CMC team, your role is to establish and drive the regulatory activities for our vaccine candidates through clinical development to market approval.

We are currently looking for a:

CMC Quality & Regulatory Affairs Manager, 80-100%

Your responsibilities will include:

• Managing regulatory operations for our vaccine candidates as they progress toward the market
• 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
• Overseeing the supply chain for LimmaTech’s vaccine candidates
• 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.

If you meet the requirements of this exciting position and want to contribute to our mission, we would love to hear from you. Please submit your detailed application, including a motivation letter, CV, diplomas and reference letters as one PDF file. Incomplete applications and applications via Linked In that only contain a CV will not be considered. Please apply directly via our website, choose the vacancy on the right-hand side and fill in the application form. Please press the “Submit” button to send your detailed application.

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