Global Regulatory Affairs Professional

18 hours ago


Jodhpur, India beBeeRegulatory Full time

Regulatory Affairs ExpertiseThe position of Regulatory Affairs Specialist entails the management of regulatory submissions for various products across multiple countries.Author, compile, and submit comprehensive dossiers to global health authorities.Conduct dossier gap analysis and identify document and data gaps.Convert and prepare dossiers in diverse formats.Manage end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions.Coordinate responses to health authority queries through cross-functional collaboration and data collation.Maintain a strong command over CMC, clinical, non-clinical, and administrative documentation.Manage regulatory submissions for multiple products across multiple countries simultaneously.Utilize project management tools to track project milestones, timelines, and deliverables.Ensure efficient time and resource allocation to meet submission deadlines.Foster seamless communication between central regulatory, regional teams, and stakeholders.8–10 years of core experience in Regulatory Affairs.Strong understanding of global dossier formats, submission pathways, and lifecycle management.Excellent cross-functional communication and coordination skills.Proven ability to manage complex multi-country regulatory portfolios.



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