Job Description:

DMF API Submission experience is must

- Preparation of Recent 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

📌 Executive / Senior Executive - Regulatory Affairs (Ahmedabad)
🏢 SDP HR Solution
📍 Ahmedabad