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.
CMC Regulatory Affairs Snr Mgr (Biologics) 12 month Contract in Oxford employer: Hays Specialist Recruitment Limited Careers
Hays Education is an exceptional employer, offering a supportive and collaborative work environment for SEN SLD/PMLD teachers in the Hounslow/Hillingdon area. With access to exclusive vacancies, ongoing professional development, and a dedicated consultant to guide your career, you will find ample opportunities for growth while making a meaningful impact on the lives of pupils with special educational needs. Join us to be part of a community that values inclusivity and fosters both personal and professional development.
Contact Details:
Hays Specialist Recruitment Limited Careers Recruitment Team
