Senior Manager Regulatory Affairs

Job Description

Job Title: Senior Manager Regulatory Affairs Company: Ascent Meditech Ltd. Location: Goregaon, Mumbai Experience Required: 3–5 years in Regulatory Affairs (preferably in the pharmaceutical/medical devices/healthcare industry) Notice Period: Immediate to 1 month Job Description: Ascent Meditech Ltd. is looking for a committed and detail-oriented Senior Executive – Regulatory Affairs to join our team. The ideal candidate will be responsible for managing and coordinating all regulatory activities related to product registrations, artwork compliance, export documentation, and certifications across various international markets. Key Responsibilities: Coordinate with the manufacturing unit for required documents during the registration process and respond to authority queries. Work with the artwork department to ensure packaging and labeling are compliant with country-specific regulatory requirements. Liaise with legalization agencies , embassies , and Chambers of Commerce for document attestation and legalization. Prepare and send packing instructions to the factory for export orders; manage related queries if any. Prepare dossiers for registration and re-registration in compliance with international guidelines and manage related correspondence. Generate and manage barcodes using the GS1 portal ; maintain product codes for the full portfolio. Coordinate with external agencies/consultants/importers for certifications such as CE Certification and plant inspections . Maintain and update the regulatory database for all ongoing and completed submissions. Handle the quotation and approval process with external agencies. Arrange documentation as per requirements from inspection agencies for pre-shipment inspections . Candidate Profile: Bachelor's/Master’s Degree in Pharmacy, Life Sciences, Chemistry, or a related discipline. Strong understanding of international regulatory requirements and documentation processes. Hands-on experience in dossier compilation, registration, and CE marking processes. Familiarity with GS1 barcode generation and export compliance procedures. Excellent communication and coordination skills with internal and external stakeholders. Strong attention to detail and ability to manage multiple regulatory tasks simultaneously. Why Join Us? At Ascent Meditech Ltd., you’ll be part of a dynamic and growing healthcare company committed to innovation and global standards. We offer a collaborative work environment, learning opportunities, and exposure to international markets. How to Apply: 📧 Email your updated resume to: aniket@ascentmeditech.com 📞 Contact: 8828660764 📅 Apply immediately if you can join within 30 days! Show more Show less