Regulatory Affairs (CMC) Associate in Uxbridge, London

Job Title: Regulatory Affair (CMC) Associate

Overview:
The Regulatory Affairs (CMC) Associate 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 life cycle. Support may include organising, managing and executing on regulatory CMC projects and submissions. Tasks may include creating and/or maintaining submission time lines 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.

What we would like to hear about you:

- Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project.
- Strong organisational skills with attention to detail.
- Excellent time management skills and ability prioritise workload.
- Project management skills.
- Adept interpersonal and communication skills (both verbal and written).
- Ability to work both independently and as a member of a team.

What we would like to hear about your background:

- Degree in life sciences, biochemistry, or chemistry
- Any previous experience in bio-pharmaceutical or pharmaceutical industry
- Familiarity with eCTD structure
- Motivated with initiative to learn quickly
- Any previous experience in CMC, including preparation of submissions to Agencies

Disclaimer:

This vacancy is being advertised by either Advanced Resource Managers Limited, Advanced Resource Managers IT Limited or Advanced Resource Managers Engineering Limited ("ARM"). ARM is a specialist talent acquisition and management consultancy. We provide technical contingency recruitment and a portfolio of more complex resource solutions. Our specialist recruitment divisions cover the entire technical arena, including some of the most economically and strategically important industries in the UK and the world today. We will never send your CV without your permission. Where the role is marked as Outside IR35 in the advertisement this is subject to receipt of a final Status Determination Statement from the end Client and may be subject to change.