About the job
§ Authoring and Review of ANDA/505(b)(2)/MAA as per applicable regulations and dossier checklists.
§ Ensure adequacy and completeness of dossier through regulatory guidance, ANDA MAPP and RTR checklists and templates.
§ Review of critical documents viz., PDR, QBD approach, Validations, specification, MPCR’s, stability protocols, data, and Jos.
§ Assessments and adequate responses to deficiencies, additional data requirements.
§ Preparation, review and tracking of correspondence, scientific advice, and meeting packages.
§ Tracking and timely responses to email requests and notifications received from Health Agencies.
§ Interaction with CFTs (formulation, analytical, API supplier, and project management), customers, consultants and provide the necessary regulatory inputs.
§ Identify all open issues and anticipate the queries/expectations from the agency at every stage of the product development.
§ Review and closure of all the change controls/equivalents in timely manner with adequate regulatory advice.
§ Publishing and critical review of compiled dossier in eCTD format using dossier management tools.
§ Validation and Submission of published dossier to the agency through ESG, EMA and CESP portals.
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