Regulatory Affairs Associate
CK Group are recruiting for a Regulatory Affairs Associate - CMC to join a biopharmaceutical company at their site based in Uxbridge on a contract basis for 12 months.
- 20.50 per hour PAYE
Regulatory Affairs Associate Role:
- The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the Chemistry, Manufacturing and Controls (CMC) function, which is responsible for Module 3 of regulatory submissions across phases of product development from clinical to lifecycle.
- Support may include organizing, managing and executing on regulatory CMC projects and submissions.
- Tasks may include creating and/or maintaining submission timelines and tables of contents, formatting of documents per styleguide, scheduling meetings, 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
- Experience in CMC, including preparation of submissions to Agencies
Company: 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.
Location: This Regulatory Affairs Associate role will be based at our clients site in Uxbridge, Greater London.
For more information, please contact LucyStendall on 01246 457739 or email firstname.lastname@example.org. Please quote reference 49952