Executive / Senior Executive Regulatory Affairs

Year Ahmedabad, Gujarat, India

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DMF API Submission experience is must

Preparation of New Drug Master Files as well as DMF amendments for Brazil, US, and ROW market according to respective agencies requirements.
Preparation of Applicant part of DMF for Brazil, US, and ROW market.
Preparation of all administrative statements for respective authority requirements.
Drafting of regulatory response for deficiencies received from regulatory authorities as well as for customers queries.
eCTD publishing for DMF to respective Authority.
Adequately review of vendors documents of key starting material/Raw materials/ intermediates of API as per regulatory requirements.
Review of documents like AMV, PDR, TTD, characterisation report and support to R&D team during API development.
Preparation of Change Notification to customers.
Review and maintenance of change control compliance data for regulatory filing in respective markets.
To coordinate with CFTs like R&D, QA, QC, ADL, and production to get supporting documents as per filing requirements

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