Executive / Senior Executive- Regulatory Affairs API

2 months ago

mumbai, India Unichem Laboratories Limited Full time

Job description

Responsibilities

  • Compile and submit registration dossiers and eCTD submission (ACTD / ASMF / CDMF / CEP / JDMF / KDMF / USDMF / TD Brazil/ Technical Package) to the international health authorities and customers.
  • Prepare LOA (DMF) / LOE / LOC & other declarations as per customer's requirement & handle queries received from Bulk Drug Marketing Dept.
  • Maintain the files of each API (raw data for related DMF) received from various concerned department, inward & outward documents entries, follow-up for the documents and stationery required specifically for compiling the registration dossier as per set standards.
  • Send reply to the technical queries / deficiency letter received from customer / regulatory authority.
  • Fill up technical information related to regulatory affairs function in the GMP / audit questionnaire.
  • Review API / stability / raw material / intermediate & In process specifications & relevant STP prepared by PRA & PR for regulatory filings.
  • Co-ordinate for all activities / requirement related to Bulk Drug Marketing Department and any other responsibility assigned by Head of the Department in absence of immediate senior.
  • Participation in preparation and review of monthly reports for activities related to API regulatory Submission.

Desired Skills

  • Should have good documentation practices.
  • Should have good experience in API regulatory affairs.
  • Must have hands-on experience in eCTD DMF compilation and eCTD software handling experience.
  • Good technical knowledge, review skills, and understanding of regulatory submissions.
  • Should have good analytical and learning attitude.

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