Senior Regulatory Affairs Manager

4 days ago


guntur, India beBeeRegulatory Full time

Regulatory Affairs Specialist PositionKey Responsibilities:Manage the compilation and submission of regulatory dossiers to global health authorities.Conduct thorough dossier gap analysis and identify document data gaps across all CTD modules.Preset, prepare, and convert dossiers in multiple formats including eCTD, ACTD, and CTD.Oversee end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions.Collaborate with cross-functional teams to coordinate responses to health authority queries.Project Planning & Management:Lead regulatory submissions for multiple products across various countries simultaneously.Utilize project management tools to track project milestones, timelines, and deliverables.Ensure efficient time and resource allocation to meet submission deadlines.Facilitate seamless communication between central regulatory, regional teams, and client stakeholders.Requirements:A minimum of 8-10 years' experience in Regulatory Affairs handling submissions across regulated RoW markets.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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