Hetero drugs Ltd Recruitment Details April 2021
Department:Regulatory Affaris
Designation:Executive/Sr.Executive
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 requirement.
• Preparation of amendments/ Annual Reports to USDMFs, CEP variations, EDMF Updates, Biannual updates to Canada DMFs and Annual updates to Korea DMFs, Japan DMFS.
• Review and approval of change controls.
· Submission of notifications to the customers pertaining to regulatory submissions as per the applicability.
Responding to deficiency letters received from various regulatory agencies like USFDA, EU Agencies, TGA, Health Canada etc.
• Hands-on experience in Electronic
submissions-Lorenz. Maintaining query database and response timelines.
• Tracking of variation submission timelines
Application process :-
Check out this job at Hetero Drugs Ltd: https://www.linkedin.com/jobs/view/2484166418
