Associate CMC Regulatory Affairs
CK Group are recruiting for an Associate CMC Regulatory Affairs to join a biopharmaceutical company at their site based in Uxbridge on a contract basis for 12 months.
Salary: £15.00 per hour PAYE.
Associate CMC Regulatory Affairs Role:
- The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development.
- Support may include organizing, managing and executing on regulatory CMC projects in support of regulatory submissions.
- Tasks may include formatting of documents per style guide, searching for and organizing data from regulatory repository systems, drafting meeting agendas and minutes, managing document reviews, and other tasks as requested.
- Degree in Life Sciences, Biochemistry, or Chemistry.
- Experience in biopharmaceutical or pharmaceutical industry.
- Familiarity with eCTD structure.
- Motivated with initiative to learn quickly.
- Experience in CMC, including preparation of submissions to Agencies.
- Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project.
Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
This Associate CMC Regulatory Affairs role will be based at our clients site in Uxbridge, Greater London.
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 56362 in all correspondence.