Roles and Responsibilities :
Preparation and reviewing of CTD and ACTD dossier.
Co-ordination with Plant and R&D; to collect inputs required for Regulatory Submission.
Co-ordination with plant for Regulatory compliances.
Timely achievement of monthly plan & timely query response.
Gap Analysis/Updation of Master data.
Get feedback from all the countries for respective variation, and their timely submission.
renewals.
Master data Updating.
Follow ups with plant for documentation regularly and review meeting.
skills:
eCTD, CTD, Validation, ICH requirements, USFDA Filings,
WHO Prequalification, MCC South Africa for Biological and
Biotech products
Has exposure to in-licensed dossier filing and out licensin