NMS Consultant
Website:
nmsconsultant.com
Job details:
Key Responsibilities:
Handle preparation, review, and submission of ANDA filings for US market.
Manage eCTD submissions including initial filings, amendments, supplements, and annual reports.
Coordinate with cross-functional teams (R&D, QA, QC, Manufacturing) for dossier compilation.
Ensure compliance with USFDA guidelines and regulatory requirements.
Review technical documents such as CMC sections, stability data, and specifications.
Respond to deficiency letters (IRs, CRLs) from USFDA within timelines.
Support pre-approval inspections (PAI) and regulatory audits.
Track submission timelines and maintain regulatory databases.
Manage post-approval changes and lifecycle management activities.
Stay updated with changing regulatory guidelines and implement necessary changes.
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