GM

Job Description : GM – Regulatory Affairs (Vaccines) NETHERLANDS Open to International candidates Qualification: M.Pharm. (Mandatory) Experience: 25+ years in Regulatory Affairs – Vaccines Proven experience in handling regulatory submissions for domestic and international markets. Strong exposure to vaccine product registration and lifecycle management. Lead Regulatory Affairs activities for vaccine products across global markets. Prepare, review, and submit regulatory dossiers (CTD/eCTD) in compliance with country-specific requirements. Coordinate with R&D, Quality Assurance, Manufacturing, Clinical, and other cross-functional teams to support product registrations. Manage regulatory submissions, approvals, variations, renewals, and post-approval changes. Liaise with national and international regulatory authorities to ensure timely approvals. Monitor evolving global regulatory guidelines and assess their impact on business operations. Ensure regulatory compliance throughout the product lifecycle. Support audits, inspections, and responses to regulatory queries. Strong knowledge of global regulatory requirements for vaccine products. Hands-on experience with CTD/eCTD dossier preparation and submissions. Excellent understanding of WHO, USFDA, EMA, MHRA, and other international regulatory guidelines. Strong leadership, project management, communication, and stakeholder management skills. Ability to manage multiple regulatory projects within strict timelines.

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