Associate Regulatory Affairs
CK Group are recruiting for a Regulatory Affairs Associate to join a biopharmaceutical company who are based in Uxbridge on a contract basis for 12 months.
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. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Location:
The role is based in Uxbridge and offers hybrid working.
Salary:
£15.01phr PAYE or £19.50phr Umbrella.
Regulatory Affairs Associate Role:
- Provide 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 style guide, scheduling meetings, drafting meeting agendas and minutes, managing document reviews and other tasks as requested.
Your Background:
- Educated to degree level or above in life sciences or a related field.
- Experience in the biopharmaceutical or pharmaceutical industry.
- Experience in a Regulatory Affairs role in CMC, including preparation of submissions to Agencies and familiarity with eCTD structure.
- Proficient in Microsoft Office suite, especially Word, Excel, PowerPoint and Project.
- Excellent communication, organisation and time management skills.
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 104511 in all correspondence.