Regulatory Affairs Associate
- Experience Level
- Entry level
Regulatory Affairs Associate (CMC)
12 month initial contract - 24 months guaranteed
Competitive hourly pay rate
Global biopharmaceutical company
37.5 hour week commitment
APPLICANTS MUST BE BASED IN THE UK AND HAVE THE RIGHT TO WORK IN THE UK UPON APPLICATION
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.
What we are looking for:
Desire to learn Regulatory Affairs CMC and global submission strategy;
* Strong organizational skills with attention to detail;
* Proficient time management skills and ability prioritize workload;
* Ability to work both independently and as a member of a team;
* Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project;
* Qualified to work in the UK without employer sponsorship;
o Bachelor's or Master's degree with 1 to 2 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical or related scientific experience