Senior Regulatory Associate - CMC
Proclinical are in partnership with a pharmaceutical company in search for a Senior Associate Regulatory Affairs CMC. The Senior Associate Regulatory Affairs (CMC) will provide 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 organising, managing and executing on regulatory CMC projects and submissions.
You will be expected to create and maintain 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.
Skills and Requirements
- Degree in life sciences, biochemistry, or chemistry
- 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
- Experience in CMC, including preparation of submissions to Agencies
- Adept interpersonal and communication skills (both verbal and written);
- Ability to work both independently and as a member of a team.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.