HEREO - Openings for Regulatory Affairs - Bulk Drugs / API @ Hyderabad - PHARMA WISDOM

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Monday, 22 February 2021

HEREO - Openings for Regulatory Affairs - Bulk Drugs / API @ Hyderabad

 

REGULATORY AFFAIRS/EXPERIENCE-BULK DRUGS/API-HYDERABAD

Department: Regulatory Affairs

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

Desired Candidates Please Share Your Updated Resume vivek.s@heterodrugs.com


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