Regulatory Affairs Associate I Job in Watson Pharma Private Limited at Mumbai

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