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 Department.
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.
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.
Seniority level
Not Applicable
Employment type
Full-time
Job function
Other
Industries
Pharmaceutical Manufacturing
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