Job Detail

Assistant Manager- Regulatory (R &D) - NEON LABORATORIES LIMITED

Date Posted: Jun 11, 2021
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Job Detail

  • Job Type:
    Full Time/Permanent
  • Job Industry:
    Pharmaceuticals/Clinical Research
  • Location:
  • Company:
  • Shift:
    General Shift
  • Career Level:
  • Positions:
  • Experience:
    to Years
  • Gender:
    No Preference
  • Degree:
    Masters / Post-Graduation
  • Apply Before:
    Aug 10, 2121

Job Description

Preparation of applicant part/ technical package for customers and ensure all regulatory documents incorporated in the applicant part or technical package
Preparation of DMFs in CTD for registration in regulated market Europe, USA, Japan, Australia etc
Overview of specification, test merthods, Analytical method validations, and customer compliments related to regulatory market
Review of regulatory documents on reciept from various departments before incusion in DMFs/ technical package
Preparation and submission of responses on customer/ Health authorities queries as per current regulatory requirements
Ensure timely preparation of query response/ applicant part request received from customers
Issuance. maintenance and tracking of the database for LOA, CEP,LOE,LOA to CEP and other essential
Declarations requested by customer
Discuss and co-ordinate with cross functional teams for finalization of documents
Preparation, updation & maintenance of technical regulatory document


Skills Required

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