Roles Responsibilities
Change control assessments for EU other international markets Completing initial RA assessment in GCCM trackwise
Creating regulatory submission task
Coordinating with Canada site RA cross functional team and submission RA and finalization of change classification
Compilation of variation package and providing to submission RA
Compilation of US Annual report package for Canada site Intimating to the respective sites for supporting documents after receipt of day 0 mail
Reviewing the documents
Preparing of tracked changes copy of index from previous annual report Finalizing the AR package and dispatching to submission RA within 30 days of receipt
Preperation and submission of ANDA product monograph update to health canada
Updating the product monograph for canadian products as per the canadian reference product within 30 working days
Qualifications 36 years of relevant experience with MSC BSC M Pharm B Pharm as an education Function Regulatory Affairs Sub Function Medical Regulatory Affairs