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.