Company Introduction
Sun Pharma is a global pharmaceutical organization engaged in the development and supply of branded and generic medicines across regulated and emerging markets.
Core Responsibilities
- Prepare country specific registration dossiers using Common Technical Document modules stored in regulatory publishing folders.
- Compile variation submission packages by updating approved product information documents and annotated labels.
- Respond to regulatory authority queries by drafting clarification letters supported by reference data files.
- Track lifecycle changes using submission tracking sheets maintained for MENA market products.
- Review stability and quality summaries received from manufacturing sites before inclusion in dossiers.
- Upload finalized submission files into electronic submission systems used by regional authorities.
Skills and Technical Exposure
- Common Technical Document preparation guidelines.
- Electronic regulatory submission systems.
- Product information and labeling documents.
- Stability study summary reports.
- Regulatory submission tracking spreadsheets.
Experience Context
- Work is performed in a corporate regulatory affairs office environment.
- Submissions cover multiple products across several MENA regulatory agencies.
- Absence of this role results in delayed approvals and blocked product availability.
How to Apply
Rosemary.varghese@sunpharma.com