Drug Regulatory Affair(DRA)

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