Role Objective

The role will be responsible for preparing, reviewing, and filing high-quality regulatory dossiers for Formulations in targeted Emerging Markets and Rest of World (ROW) regions. This role ensures strict compliance with country-specific regulatory guidelines, manages post-approval product lifecycles, coordinates with internal technical teams, and handles client and health authority queries to secure timely market approvals.

Key Responsibilities:
- Dossier Management: Collate, prepare, and file dossiers accurately and on time for Formulations and API products to obtain licenses in targeted Emerging Markets/ROW regions.
- Compilation & Publishing: Perform e-CTD compilation, publishing, and submission of DMFs and dossiers to customers or Health Authorities.
- Document Checklists: Prepare comprehensive documentation checklists for regulatory filings customized to country-specific regulatory requirements.
- Lifecycle Maintenance: Manage submissions for product renewals, re-registrations, and tender filings across assigned regions.
- Technical Documentation Review:



Collate and conduct first-level reviews of technical documentation, including stability data, Technical Transfer Documents (TTD), Pharmaceutical Development Reports (PDR), and method validation reports.
- Specifications Review: Conduct initial regulatory reviews of specifications for APIs, semi-finished products, and finished drug products.
- Artwork & Labeling: Review labeling and artwork for Formulations to ensure compliance with specific market requirements.
- Change Control Management: Review and perform regulatory impact analyses on internal change controls, proposed post-approval changes, and vendor-notified changes per country-specific guidelines.
- Amendments & Supplements: Prepare and file post-approval amendments, supplements, and annual reports to ensure continuous compliance.
- Query Resolution: Assist in assessing and resolving technical queries received from customers, agencies, an

📌 Senior Officer- Regulatory Affairs (Mumbai)
🏢 USV
📍 Mumbai