- Dossier Compilation & Submission: Prepare, review, and compile regulatory dossiers in CTD, ACTD, and country-specific formats for ROW, CIS, Africa, SEA, and Asian regions.
- Query Management: Promptly address and resolve technical queries raised by Ministry of Health (MOH) / FDA authorities of respective countries to ensure timely product approvals.
- Lifecycle Management: Manage post-approval changes, variations, and timely renewal of product registrations and manufacturing licenses.
- Artwork & Labeling Review: Review and approve product packaging artwork, labels, and Patient Information Leaflets (PIL) as per the specific countrys regulatory guidelines.
- Cross-Functional Coordination: Collaborate with R&D;, Quality Control (QC), Quality Assurance (QA), Production,
and Export/Logistics teams to gather required technical documents and data.
- Regulatory Intelligence: Track and update internal teams on changing regulatory guidelines and import/export compliance rules in the assigned regions.
Preferred candidate profile We are looking for a energetic and result-oriented Regulatory Affairs Executive with 2 to 5 years of experience in handling regulatory compilations and submissions for international markets. The ideal candidate will be responsible for managing product registrations and life-cycle management across ROW, CIS, Africa, SEA, and Asian markets.