Executive - Regulatory Affairs R

Executive - Regulatory Affairs
Fairlink Placements - Navi Mumbai, Maharashtra

Should able to compile dossiers for US/Canada market in CTD / eCTD format Should able to handle queries of FDA, review of data, experience of preparing module I, II, III, IV V Must have experience on post approval activities Desired Candidate Profile: Responsible for drafting, compilation. Minimum 2 to 3 years experience in review of various supplements like CBE, CBE-30, PAS and annual reports for administrative, labeling and CMC changes in US/Canada market, must have experience on post approval Industry: Pharma / Biotech / Clinical Research
 Exp: 2-5 Years Location: Mumbai 
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