Global Regulatory Compliance Expert

2 weeks ago


india beBeeRegulatoryAffairs Full time

Regulatory Affairs ProfessionalThe Regulatory Affairs Specialist will be responsible for authorizing, compiling and submitting regulatory dossiers to global health authorities. This includes submissions to USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA and others. Their role involves conducting dossier gap analysis, converting and preparing dossiers in multiple formats and managing end-to-end preparation and submission of ANDA, NDA, BLA, MAA and other lifecycle submissions.In addition to regulatory submissions, the Specialist will also be responsible for project planning and management. This includes managing regulatory submissions for multiple products across multiple countries simultaneously, utilizing project management tools to track project milestones, timelines and deliverables, and ensuring efficient time and resource allocation to meet submission deadlines.To be successful in this role, the candidate should have 8-10 years of core experience in Regulatory Affairs, handling submissions across regulated and RoW markets. A strong understanding of global dossier formats, submission pathways and lifecycle management is also required. Excellent cross-functional communication and coordination skills are essential for this position.Key Responsibilities:Authorizing, compiling and submitting regulatory dossiers to global health authorities.Conducting dossier gap analysis.Converting and preparing dossiers in multiple formats.Project planning and management.



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