Global Regulatory Compliance Specialist

1 week ago

Eluru, India beBeeRegulatory Full time

Job Title:Regulatory Affairs CoordinatorJob Responsibilities:Prepare and submit regulatory dossiers to global health authorities, including the FDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others.Conduct dossier gap analysis to identify document and data gaps across all CTD modules (1–5).Convert and prepare dossiers in multiple formats, including eCTD, ACTD, and CTD.Manage end-to-end preparation and submission of drug applications, variations, renewals, and withdrawals.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 to ensure successful global submissions.Key Skills and Qualifications:8–10 years of experience in Regulatory Affairs, handling submissions across regulated and ROW markets.Strong understanding of global dossier formats, submission pathways, and lifecycle management.Excellent communication and coordination skills.Ability to manage complex multi-country regulatory portfolios.Benefits:This role offers an exciting opportunity to work in a dynamic team and contribute to the success of our organization.

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