Hiring for Executive Regulatory Affairs (domestic Market) for Mumbai in Mumbai, for Exp. 2 - 4 yrs at India Pharma People.
MedWiz Mumbai, Maharashtra, India
Apr 22, 2018Full time
Job Description:Greetings From India Pharma We are considering you for the role of Executive Regulatory Affairsfor our Client. below the details- Company : Pharma Designation :- Executive RA Qualification :- B. Sc./M. Sc./B. Pharm Location :- Mumbai Job Description :- The role will involve expertise in D & amp amp C Act and Rules as well as FSSAI regulations with experience in FDA related activities. This profile will make sure that timely and robust functional/cross-functional coordination (R& amp amp D, QC, Marketing, Legal, Production, etc.), transparent execution and implementation of regulatory affairs and safety processes. Prepare registration dossier for procuring certificates/license from local FDA, DCGI and FSSAI. This would entail thorough familiarity with FDA, CDSCO & amp amp FSSAI online portal, Drugs & amp amp Cosmetics Act and its various Schedules e.g. Sch Y, M, etc. Confirm product formula and label acceptability, as well as the receipt of necessary licenses, prior to the release of product. Co-ordinate with QC and R& amp amp D divisions for technical documents (manufacturing documents like batch records, specifications, analytical methods, validation reports, and stability data) required to be incorporated in the registration dossiers. Formulate and implement statutory requirements pertaining to the artworks of the products (label, carton, package insert, patient information leaflet, etc.). If you are interested share your resume on email@example.com For more info plz call on 7720080601