Formulation Regulatory Affairs Executive/ Assistant Manager

Role & responsibilities

• Keen Knowledge on Regulatory guidelines for finished product registration.
• Dossier compilation as per guidelines.
• Compilation and review the product dossiers for submission in CTD, ACTD.
• Gap analysis of the dossier and addressing the gaps before submission to MOH.
• Handling the customer and MOH queries.
• Life cycle management of the product.
• Development report, scale up report, specification, COA, stability protocol and Process validation protocol.
• Documents review (Specification, STP, Analytical method validations, Development report and validation reports, BMR, BPR, PVP/R and stability).
• Post approval experience to file the applicable variations timely.
• Knowledge on EAEU, ICH and EMEA guidelines.
• Re-registration (Renewal) procedures.
• Administrative documents requirements (COPP, Mfg. License and Import License) .
• Registration information management system updates on regular basis.