Global Regulatory Affairs Expert

2 weeks ago

lucknow, India beBeeRegulatory Full time

Regulatory Compliance ManagerA Regulatory Compliance Manager will be responsible for overseeing the management of regulatory submissions for multiple products across various countries.Coordinate the compilation and submission of regulatory dossiers to global health authorities, including USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others.Analyze dossier gaps to identify document and data deficiencies across all CTD modules (1–5).Ensure dossier conformity by converting and preparing documents in eCTD, ACTD, and CTD formats.Manage lifecycle submissions, including ANDA, NDA, BLA, MAA, and other variations, renewals, and withdrawals.Cultivate cross-functional collaboration to provide responses to health authority queries.Maintain a robust understanding of CMC, clinical, non-clinical, and administrative documentation for successful global submissions.Project ManagementUtilize project management tools to track milestones, timelines, and deliverables.Optimize resource allocation to meet submission deadlines.Foster effective communication between central regulatory teams and client stakeholders.Requirements:8-10 years of experience in Regulatory Affairs, managing submissions across regulated and RoW markets.Detailed knowledge of global dossier formats, submission pathways, and lifecycle management.Excellent interpersonal and coordination skills.Proven ability to manage complex multi-country regulatory portfolios.We offer a challenging role with opportunities for growth and development. If you have the required expertise and skills, we encourage you to apply.

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