Your new company An innovative and growing biotechnology company focused on the development of biologic therapies for serious diseases. They are a commercial stage biotechnology company with a strong clinical pipeline. Your new role
I am looking for a Senior Regulatory CMC contractor to play a key role in the development and execution of global CMC regulatory strategies across a portfolio of biologic products. Working within a highly collaborative Regulatory Affairs team, you will support products through clinical development and commercialisation, leading CMC regulatory activities across global markets. Key responsibilities include: Developing and implementing global CMC regulatory strategies for development and marketed products. Authoring, reviewing, and maintaining Module 2 and Module 3 documentation for regulatory submissions. Supporting IND, CTA, IMPD, BLA and MAA submissions and life cycle management activities. What you'll need to succeed Strong Regulatory Affairs CMC experience with biologics products. Experience preparing and managing Module 3 documentation and global CMC submissions.
Desirable experience: Preparation and submission of IMPDs, BLAs, NDAs and MAAs. Experience supporting at least one successful marketing application. Previous involvement in HA meetings and regulatory negotiations.
What you'll get in return This is an excellent opportunity to join a growing biotechnology organisation at a pivotal stage in its development. You'll gain exposure to innovative biologics programmes, work closely with experienced cross-functional teams, and play a visible role in shaping global CMC regulatory strategy. Initially offered as a 12-month contract, the position has strong potential for extension, providing the opportunity to make a meaningful impact while building valuable experience within a dynamic and collaborative environment. A competitive day rate and flexible working arrangements are also available.
What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.
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