Regulatory Affairs/experience-bulk Drugs/api-hyderabad Job in Hetero Drugs Limited

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 (Amendments, Annual Reports) to various Health Authorities
• Responsible for organizing meetings to address queries and variation submissions.
• Rendering customer support by preparing technical packages, Applicant" s Part Drug Master Files and responding to the technical queries received from customers.

2 years worked in organic synthetic research (PR&D) with pilot plant.

• Preparation of pharmaceutical ingredients (API) and its intermediates.
• Analytical interpretation, trouble shooting & Plant performances.