Hetero drugs Ltd – Regulatory affairs Pharma jobs in Hyderabad | Pharmaceutical industry

Hetero Drugs Ltd Recruitment NOTIFICATION  for regulatory affairs Executive/Sr.Executives position
Department: Regulatory Affairs
Designation: Executive/Sr.Executives 
Industry: Pharma/API
Experience: 2 to 6 years
CTC: Negotiable
Job Location: Sanath Nagar, Hyderabad
Roles And Responsibilities
  • Preparation of Drug Master Files (DMF) in CTD / ECTD / Nees format for US, European Countries, Canada, Australia, Japan, GCC, Turkey, and Korea as per customer/ business requirements.
  • Keen Knowledge of Russian market regulatory guidelines for finished product registration.
  • Dossier compilation as per EAEU guidelines.
  • Gap analysis of the dossier and addressing the gaps before submission to #MOH.
  • Handling the customer and MOH queries.
  • Documents review (Specification, STP, analytical method validations, Development report, validation reports, BMR, BPR, PVP/R, and stability).
  • Post-approval experience to file the applicable variations timely.
  • Knowledge of EAEU, ich, and EMEA guidelines.
  • Re-registration (Renewal) procedures.
  • Administrative documents requirements (COPP, Mfg. License, and Import License).
  • Registration information management system updates on a regular basis.
Application process:-  Interested candidates can drive their CV to premkumar.m@hetero.com
1617249740715915 0


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