GM

Job Description : VP – REGULATORY AFFAIRS | VACCINE DIVISION IRELAND Open to International candidates Key Requirements ? Qualification: M.Pharm / M.Sc. ? Experience: 20+ years of experience in Regulatory Affairs ? Experience in vaccine manufacturing companies only is mandatory ? Strong expertise in regulatory strategy, submissions and approvals for vaccine products ? Experience in handling regulatory interactions with relevant national and international authorities ? Strong knowledge of GMP, regulatory guidelines, product registrations and lifecycle management ? Proven experience in managing regulatory teams and complex submissions ? Excellent strategic, analytical, communication and stakeholder-management skills Key Responsibilities • Develop and execute regulatory strategies for vaccine products • Lead preparation, review and submission of regulatory dossiers and applications • Manage product registrations, renewals, variations and lifecycle activities • Coordinate regulatory responses, queries and interactions with authorities • Ensure regulatory compliance throughout the product lifecycle • Partner with R&D, QA, QC, Manufacturing, Medical and Business teams • Monitor evolving regulatory guidelines and assess their business impact • Drive timely regulatory approvals for new products and markets • Lead, mentor and develop the Regulatory Affairs team

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