Drug Regulatory Affairs (DRA)

Job  description – 

    • Prepare  CTD, ACTD  Dossiers and file regulatory submissions
    • Perform assessments of new or revised products
    • Manage complaint documentation (including investigation and
    • closure)
    • Respond to inquiries from regulatory bodies
    • Should be technically well versed with requirements for medicines with fare  knowledge about medicines, food supplement,
    • To Coordinate with relevant department for arranging documents
    • To prepare / compile dossier for allocated products / countries
    • To coordinate with account department for handling Local FDA fees / transfer of  amount for legalization etc
    • To coordinate with courier agency for dispatches of dossier /sample
    • To make   timely entries of submissions / dispatches

Qualifications :-

  • A bachelor’s degree in B. Pharma
  • Experienced 1 year to 3 years
  • Excellent communication skills
  • Should be aware about Microsoft office [word / Excel/ PPT] – Good in data management

Position :- 2

Job Category: Corporate Office
Job Type: Full Time
Job Location: Noida

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