Hiring for Regulatory Affairs Executive in Mumbai, Gujarat Other for Exp. 1 - 4 yrs at DIgnity Consu (Job in Ahmedabad)
(Not Shown) (Please mention IndiaDynamics.com when contacting)
Job Description:Core Responsibility Preparation and review of regulatory documents (Dossier, DCTD, ACTD, DMF, BA/BE, APR, MFR, MSDS, PV) Application for Test license, manufacturing License, product permission, Site registration Regulatory Query Response coordination Evaluation of formulation / analysis / preclinical / clinical reports. Evaluation of certificates / reports / DMF received from RM manufacturers Internal co-ordination to compile technical data and product review Timely reply to queries raised against dossier submissions.