CMC Writer (Vaccines/Biologics) – Global CRO – Remote (UK / EU only) - £competitive, bonus, benefits

This is an exciting time to join this market leading, global CRO based in the UK / EU. You’ll be predominantly

The Company

A global, well known CRO are now recruiting for a CMC Writer (Vaccines / Biologics) to join their already well-established team. You’ll be working directly with one of their major pharmaceutical clients on an exciting pipeline of new products. Offering great training and development, this company has a huge interest in developing their employees to a high standard.

• Global CRO
• Working across exciting vaccines / biologic projects with one major client (global pharma)
• Very exciting projects to work on and upcoming pipeline
• Excellent career progression opportunities to Senior Manager, Associate Director and beyond
• Great training and development

The Role

Working on a number of exciting projects for one major pharmaceutical client, the CMC Writer (Vaccines / Biologics) will be responsible for;

• Develop submission plans and contribute to the execution of timely and innovative regulatory strategies
• Collaborate with the Global and Regional RA CMC Leads to provide regulatory support for assigned projects
• Communicate with Regulatory Operations on the planning of global Clinical Trial Applications, marketing applications and post-approval supplements and variations
• Contribute to the development of and to the definition of the CMC content requirements for strategies for timely approval of regulatory filings throughout the product life cycle (IND, IMPD, NDA, BLA, MAA)
• Prepare and coordinate the review and approval of submission-ready documents
• Review submission documents to ensure messaging is clear and consistent within and across documents, and to perform a final copyediting check

You

To apply for this role as CMC Writer (Vaccines / Biologics) our client is hoping for someone with the following skills and experience

• Experience preparing CMC sections of INDs, NDAs, and supportive amendments and supplements (ICH Modules 2 and/or 3)
• Degree in scientific discipline or advanced degree
• Ample experience in biopharmaceutical regulatory experience
• Thorough understanding of the drug development process for all phases of pharmaceutical development
• Comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance

What should you do next?

This CMC Writer (Vaccines / Biologics) role is one not to be missed; it encompasses the opportunity to work on a highly successful team on some new and exciting products with one major pharmaceutical client.   To discuss this CMC Writer (Vaccines / Biologics) role further or to find out about other Regulatory Affairs / Regulatory Writer jobs I’m currently working on, please get in touch or hit apply to submit your current CV.

Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.

Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.