Sr. Associate Regulatory Affairs - CMC

Overview: The Senior Associate Regulatory Affairs (CMC) 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. 100% remote. Flexible schedule will need to adhere to Pacific coast hours Must have direct CMC experience (RA CMC, Manufacturing, Quality Control, etc.). Must be able to work independently and multi-task in a fast paced environment. Experience working on biologics and small molecules, commercial and clinical is highly desired.****** 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 • Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project

Created: 2021-11-29