Senior Global Regulatory Affairs Manager

1 week ago

hubballi, India beBeeRegulatory Full time

Global Regulatory Affairs Specialist OpportunityWe are seeking a seasoned Regulatory Affairs Specialist to join our organization and play a pivotal role in managing global regulatory submissions and ensuring compliance with health authorities.The successful candidate will be responsible for authoring, compiling, and submitting regulatory dossiers to various health authorities worldwide, ensuring timely and efficient submission of high-quality documents.They will conduct thorough dossier gap analysis to identify document and data gaps across all CTD modules, providing expert recommendations for improvement.Additionally, the Regulatory Affairs Specialist will prepare and submit ANDA, NDA, BLA, MAA, and other lifecycle submissions, as well as coordinate responses to health authority queries through effective cross-functional collaboration.A strong command over CMC, clinical, non-clinical, and administrative documentation is essential for success in this role. The ideal candidate will possess excellent communication and project management skills, with the ability to manage multiple projects simultaneously and meet submission deadlines.Project Planning & Management ExpertiseEffective utilization of project management tools to track project milestones, timelines, and deliverables.Strong ability to allocate resources efficiently, ensuring timely completion of regulatory submissions.Requirements:8-10 years of experience in Regulatory Affairs, handling submissions across regulated and RoW markets.Advanced understanding of global dossier formats, submission pathways, and lifecycle management.Superior cross-functional communication, coordination, and project management skills.

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