Formulation Regulatory Affairs Executive/ Assistant Manager

Job description

**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.