Preparation of high quality chemistry, manufacturing and control (CMC) regulatory documents for new, small molecule products, using varied information sources and liaising closely with other personnel to ensure accuracy of such records. Work to agreed deadlines, with ability to respond readily to changing events and priorities.
CMC Regulatory Affairs experience; planning, authoring, reviewing and project management of regulatory submissions.
Good written and oral communication. Demonstrated ability to focus, work with attention to detail and retain critical information.
Demonstrated team working skills, with the ability to establish strong relationships and liaise effectively with sites worldwide. Demonstrated effective time management skills.
Degree in Pharmacy, Chemistry or related discipline.
Global experience, (including EU, US, Japan and emerging markets), in the following types of CMC submissions:
Clinical trials documents.
Marketing applications for new medicines and managing the related responses to questions.
Post approval variations.