Dipal P. - 18982 Regulatory Affairs Associate from Whitby

• Well versed with regulatory knowledge - Health Canada Guidelines, Food and drug regulations, ICH guidelines, Drug development process, Data integrity, and good documentation practice. • In depth knowledge of DIN and EL application, writing SOP and CAPA, Generating change control, Response to clarifex, pre-NDS meeting request. • Working experience of preparing and compiling documents for electronic submissions for MHRA as well as EU (marketing authorization application for parallel import and various kinds of amendments, Information leaflets, packaging layouts and labels). • Working knowledge of analytical test methods and analytical instruments as per GMP and GLP.