Responsibilities:
- Preparation of the dossier as per the current prescribed guidelines of the respective regulatory authorities
- Coordinate with various departments to collect the complete set of documents.
- Review of the quality and analytical data as per the pharmacopoeia, specification, MOA, STP, batch records, stability , finished product /packaging material data for the purpose of compilation of dossier.
- Review of documents required for regulatory agencies (Viz DMF, analytical reports, process validation reports, PVP, PDR, protocols & stability data)
- Preparation of various pharmacological, preclinical and toxicological data based on published literature
- Submission of the notification to regulatory agency for the post approval changes.
- Preparation of SPC, package insert and labeling information.
- Review of vendor documents as a part of vendor qualification programmer and to communicate with supplier & manufacturer of the API & Excipients for the related vendor documents
- Preparation of template of the vendor quality Agreement and to communicate with the vendor for its final execution
- Any other work assigned by management within the scope of regulatory framework.