1. Regulatory Submissions & Maintenance

- Compile, review, and submit API DMFs (USDMF, ASMF) in eCTD / NeeS format for regulatory filings for global markets including US FDA, EMA, ANVISA, Health Canada, TGA, Medsafe and ROW agencies.

- Prepare and manage CEP applications (recent submissions, revisions, renewals, and group submissions).

- Handle DMF amendments/updates, annual updates, and notifications as per various agency requirements.

1. Agency & Customer Communication

- Ensure accuracy, consistency, and compliance of CTD Module sections with current ICH, FDA, EMA, ANVISA and other applicable guidelines.

- Maintain regulatory databases, submission trackers, and archival systems for APIs.

- Support change management filings related to process optimization, vendor change, site changes, specifications, and analytical methods.

1. CrossFunctional Coordination

- Work closely with R&D;, QA, QC, Manufacturing, and Supply Chain teams to obtain compliant technical documentation.

- Support regulatory inspections and audits by providing documentation and responses related to API registrations.

📌 Officer/Senior Officer - Regulatory Affairs (API Experience) (Solapur)
🏢 Alivus Life Sciences
📍 Solapur