Regulatory Affairs-Executive/Sr.Executive-Hyderabad(Experienced)

from 4 to 8 year(s) of Experience
₹ Not Disclosed by Recruiter

Job Description

Department:Regulatory Affairs


Experience:4 to 8 years

Roles& 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.
  • Analytical interpretation, trouble shooting & Plant performances.

Desired Candidates Share your Profile to

Role:Regulatory Affairs Manager

Salary: Not Disclosed by Recruiter

Industry:Pharmaceutical & Life Sciences

Functional Area:Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category:Drug Regulatory Affairs/Documentation

Employment Type:Full Time, Permanent



PG:M.Pharma in Any Specialization,MS/M.Sc(Science) in Any Specialization


Company Profile

Hetero Drugs Limited

M/s. Hetero Drugs Ltd is one of the Largest Pharmaceutical Company in India.
Company Info
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Contact Company:Hetero Drugs Limited

Address:7-2-A2,,,Hetero Corporae,Industrial Estate,Sanath , Nagar, Hyderabad, Telangana, India

Copyright © 2017 Hetero. All rights reserved.