Company Introduction
Bal Pharma is a pharmaceutical organization engaged in the development and commercialization of formulations across regulated and emerging international markets.
Core Responsibilities
- Compile Common Technical Document modules using regulatory submission software and validated dossier templates.
- Review Chemistry Manufacturing and Controls sections against product development reports and stability data files.
- Prepare country specific application forms and upload electronic dossiers through regulatory authority portals.
- Track product registration timelines in regulatory databases and update submission trackers with milestone dates.
- Examine approved artworks and labeling texts against master packaging specifications before variation filing.
- Draft written responses to regulatory deficiency letters using archived submission records and query logs.
Skills and Technical Exposure
- Electronic Common Technical Document publishing tools.
- Regulatory information management systems and submission trackers.
- Chemistry Manufacturing and Controls documentation sets.
- Stability study reports and bioequivalence study summaries.
- Country specific regulatory guidelines for Latin America ASEAN and African markets.
- Artwork approval files and product lifecycle management records.
Experience Context
- Work performed in a corporate regulatory office handling multiple international product dossiers.
- Exposure to simultaneous filings for semi solid liquid and solid dosage forms.
- Support provided to manufacturing plants supplying batches for registration commitments.
- Without this role product approvals and post approval variations remain pending with authorities.
How to Apply
placement@balpharma.com
