Officer/Senior Officer - Regulatory Affairs (API Experience)

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 (new submissions, revisions, renewals, and group submissions).
• Handle DMF amendments/updates, annual updates, and notifications as per various agency requirements.

2. 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.

3. 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.