Your New Company:
Join this renowned biopharmaceutical organisation dedicated to developing innovative therapies that improve patients' lives. Leaders in the industry and looking for a biologics CMC Regulatory Affairs contractor on a 12-month assignment.
Your New Role
I am seeking a Regulatory Affairs Manager - CMC (Biologics) for a 6-month contract for my biotechnology client. You will play a crucial role in developing and implementing regulatory strategies for biologics products in global markets. You will be responsible for managing the strategy and execution of submissions in late-stage clinical trials, variations, extensions, and MAAs.
Previous experience authoring CMC documents is required.
What You'll Need to Succeed:
- Strong background in biologics CMC with regulatory strategy involvement.
- Deep knowledge of regional regulations and CMC components.
- Experience working in international/global Markets, and working at late stage CTA through to post approval maintenance.
- Excellent project management and analytical skills
- Effective communication and collaboration abilities
- Up-to-date understanding of biological regulations
What You'll Get in Return:
12-month contract with scope for extension to the site only once per quarter. A strong team and an open learning environment.
What You Need to Do Now
Apply today if you are a skilled Regulatory Affairs Manager experienced in biologics CMC. Please reach out to Julia Bowden at Hays Life Sciences.