Drug Regulatory Affairs Executive

1 week ago

Noida, Uttar Pradesh, India Florencia Healthcare Full time ₹ 15,00,000 - ₹ 28,00,000 per year

1. Drug Regulatory Affairs - 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 Food supplement, medicines
  • 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 /samples
  • To make timely entries of submissions / dispatches

Qualifications :-

  • A bachelors degree in B. Pharma
  • Experienced with 1 year Should apply.
  • Excellent communication skills
  • Should be aware about Microsoft office [word / Excel/ PPT] - Good inData management

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