Hetero Drugs Ltd Recruitment NOTIFICATION for regulatory affairs Executive/Sr.Executives position
Department: Regulatory Affairs
Experience: 2 to 6 years
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.