Description
One of our large Pharmaceutical clients are currently searching for a Regulatory Affairs Associate.The Regulatory Affairs Associate (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 style guide, scheduling meetings, drafting meeting agendas and minutes, managing document reviews and other tasks as requested. Ideal candidate has:
* Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project;
* Strong organizational skills with attention to detail;
* Excellent time management skills and ability prioritize 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.
Preferred Qualifications
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
This position is currently a remote working opportunity, post COVID the successful candidate will be required to work on site in Uxbridge
Michael Bailey International is acting as an Employment Business in relation to this vacancy.