Executive / Senior Executive - RA- API

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.