Job Title
- Senior Manager
- Regulatory Affairs Job Purpose: The Regulatory & Export Documentation Executive will manage and coordinate all regulatory, documentation, and compliance-related activities necessary for product registration, export, and certification across multiple international markets. The role ensures that all documentation, approvals, and certifications meet country-specific legal, regulatory, and customer requirements while maintaining accuracy, timelines, and compliance standards.

Key Responsibilities
1. Regulatory Documentation Coordination:
- Liaise with the manufacturing unit to collect and verify all necessary documents required for product registration, re-registration, and compliance processes in various countries.
- Respond promptly to queries from regulatory authorities, importers, and internal stakeholders regarding registration documentation. 2. Artwork and Labeling Compliance:
- Coordinate with the Artwork/Packaging team to develop and update product artwork, labeling, and packaging materials in line with country-specific regulatory requirements.
- Ensure all artwork approvals are obtained prior to production or export. 3. Legalization and Attestation Management:
- Coordinate with legalization agencies for document legalization through embassies, consulates, and chambers of commerce as required for product registration and export purposes.
- Ensure timely attestation and compliance with international documentation standards. 4. Export Coordination & Packing Instructions:
- Prepare and communicate packing instructions to the manufacturing unit for export orders.
- Address and resolve queries related to packing, shipping, and export compliance. 5. Dossier Preparation & Submission:




- Prepare comprehensive regulatory dossiers for product registration and reregistration in exporting countries, adhering strictly to respective country guidelines.
- Manage follow-ups and respond to queries from regulatory authorities or importers during the review process. 6. Barcode & Product Code Management:
- Generate and manage GS1 barcodes for all products and maintain a centralized product code database.
- Ensure consistency and traceability of product codes across all regulatory and export documentation. 7. Certification & Inspection Coordination: o Coordinate with external agencies, consultants, and importers to obtain certifications such as CE Certification and other regulatory approvals. o Facilitate plant inspections or audits as per country-specific requirements. 8. Regulatory Database Management: o Maintain an up-to-date regulatory and compliance database with all registration, certification, and export-related documents. o Ensure data accuracy and readiness for internal and external audits. 9. Quotation & Approval Processes: o Coordinate with agencies to obtain quotations for regulatory services and manage the internal approval process for engagements. o Ensure timely follow-up and cost-effective vendor management. 10. Pre-Inspection Documentation Support: o Arrange and submit all necessary documents to inspection agencies for pre-shipment inspections. o Ensure completeness and compliance to prevent delays in shipment clearance. Skills & Competencies: Solid knowledge of international regulatory requirements, documentation, and export processes. Excellent coordination, communication, and organizational skills. Attention to detail with the ability to handle multiple tasks and meet deadlines. Proficiency in MS Office and regulatory database management. Ability to liaise effectively with internal teams, external agencies, and authorities.
Role & responsibilities Email:
- [email protected]

📌 Manager - Regulatory Affairs (Mumbai Suburban)
🏢 Ascent Meditech
📍 Mumbai Suburban