Company Introduction
Infinium Pharmachem Limited develops and manufactures APIs aligned with global regulatory requirements.
Core Responsibilities
- Compile CTD sections using product development reports and analytical summaries.
- Prepare variation submissions with stability data and change justifications.
- Maintain country-wise registration trackers for submitted and approved dossiers.
- Review regulatory queries and draft written responses with supporting documents.
- Archive submission records in electronic document management systems.
Skills & Technical Exposure
- CTD and eCTD compilation software.
- Regulatory submission trackers and lifecycle tools.
- Stability study reports and validation summaries.
- Electronic document management systems.
- Guidelines from USFDA, EMA, and WHO.
Experience Context
- Work is performed in a regulatory office linked to API manufacturing sites.
- Handles multiple product dossiers across regulated markets.
- Without this role, product approvals stall and market supply timelines fail.
How to Apply
hr2@infiniumpharmachem.com
