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.

Skills Required

life cycle management , EMEA, Process Validation, Regulatory