Senior Regulatory Compliance Expert

2 weeks ago


pushkar, India beBeeCompliance Full time

Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with global health authorities and managing the end-to-end preparation and submission of regulatory documents.Key Responsibilities:Author, compile, and submit regulatory dossiers to global health authorities.Conduct dossier gap analysis to identify document and data gaps across all CTD modules.Convert and prepare dossiers in multiple formats including eCTD, ACTD, and CTD.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.Project Planning & ManagementManage 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.Requirements:A minimum of 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.Excellent cross-functional communication and coordination skills.If you are a motivated and detail-oriented professional looking to advance your career in regulatory affairs, we encourage you to apply.



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