Company Introduction
The organization manufactures active pharmaceutical ingredients with global market presence and regulated facility operations.
Core Responsibilities
- Prepare DMF dossiers using CTD modules, stability summaries, and API manufacturing descriptions.
- Compile regulatory submission packages through country-specific checklists and authority-ready formats.
- Update variation files by revising approved specifications, validation reports, and change records.
- Review regulatory query letters and draft written responses supported by technical annexures.
- Maintain submission trackers documenting timelines, authority correspondence, and approval status.
- Archive regulatory documents within controlled document management systems for audits.
Skills & Technical Exposure
- CTD and eCTD submission structures.
- ICH Q7, Q1, and regional API guidelines.
- DMF preparation templates and variation formats.
- Regulatory submission tracking tools.
- Document management systems for regulated records.
Experience Context
- Works within an API manufacturing plant supporting regulated international markets.
- Handles multiple drug substances and concurrent global submissions.
- Without this role, regulatory filings stall and market approvals lapse.
How to Apply
mrunali.uttekar@bdrpharma.com
