We have urgent vacancy as RA officer/Executive having 2 to 3 Years experience in Tablet & Capsule manufacturing company.
He / She must have knowledge of Art work and Preparation of Country Dossiers for Angola, Mozambique, Tanzania, and Ecuador in A-CTD, CTD, e-CTD and General formats submissions as per ICH guidelines. Compilation and review of study reports and supporting documents for submissions to USFDA, EU, CDSCO, and other regulatory authorities. Resolution of sponsor queries and review of finished product, and WHO inclusion documents, along with artwork and package inserts.