Regulatory Operations Manager
Regulatory Operations Manager - Cambridge
A burgeoning generics pharmaceutical company undergoing rapid growth is looking to expand its team with a Regulatory Operations Manager in anticipation of upcoming, exciting projects set for 2017! The successful candidate will be instrumental in the development processes for new products, whilst ensuring compliance of the company's existing products. This position requires a good knowledge of CMC, and will have a focus on pre-approval activities.
As a Regulatory Operations Manager, your responsibilities will involve:
*Leading and planning pharmaceutical development programs for new drug products to meet regulatory requirements
*Authoring and compiling eCTD Module 3 for a number of (primarily EU) agencies
*Authoring regulatory communications for pre-approval activities
*Communicating with CMO subcontractors to ensure regulatory compliance
The ideal candidate will possess:
*A minimum of 5yrs broad regulatory experience, ideally with a background in
CMC and pre-approval activities
*A good understand of global health authorities' regulations (EU, FDA, EMA)
*A background in product development, analysis or finished dose form manufacturing is highly desirable
*A team player also capable of independent work, and managing multiple projects.
*Excellent communication skills, both written and spoken.
If you're ready for your next challenge and would like to be involved in the exciting processes behind developing regulatory strategy for new drug products in a flourishing generics company, send your CV to email@example.com. For further details, call Emilie Francis on 0121 616 3477.
Regulatory Affairs Manager, RA Manager, Regulatory, Cambridge, Hertfordshire, St Albans, Harlow, Essex, Chelmsford, Portsmouth, Milton Keynes, Stevenage, CMC, Pre-approval, Drug development, New Drug Products, Generic, Small Molecule, Module 3, Senior Regulatory Affairs Associate
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