Regulatory Affairs CMC Manager  

As we are seeing a paradigm shift within the biotech industry, the growth antimicrobial resistance is a leading concern for all those involved. Our client is at the forefront in developing innovative vaccines agaisnt AMR pathogens and in order to ramp up their manufacturing activites, they are looking for a Regulatory Affairs CMC manager with a strong scientific background to support the CMC team. Reporting to the Director of CMC, your responsilbilities will include. 

Responsibilities:

• Managing regulatory operations for our vaccine candidates as they progress toward the market
• 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

Profile:

• 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)
• Solid technical regulatory expertise. Experience in QbD, process and analytical validation, CMC-bridging strategies and with different regulatory authorities is a plus
• Excellent verbal and written communication skills in English