Senior CMC Regulatory Executive
Chemical Executive Life Sciences Pharmaceuticals
Salary £445.26p/d PAYE OR £570.68p/d Umbrella
CY Partners have an exciting opportunity for a Senior Regulatory Executive to join the small molecules development project group, with a global pharmaceutical organisation. This opportunity is based from their site in Hertfordshire, with hybrid working options.
As a Senior Regulatory Executive, you will have the opportunity to prepare 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.
You will work to agreed deadlines, with ability to respond readily to changing events and priorities.
Degree in Pharmacy, Chemistry or related discipline.
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.
Be proficient in the use of IT packages such as Word, Excel and Veeva Vault systems.
Demonstrated problem solving skills.
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.
For an informal confidential chat about this opportunity, contact Helen Tomlinson at CY Partners on 07851246847 or apply with an updated version of your CV to [email protected]