Global Regulatory Compliance Specialist

1 week ago

junagadh, India beBeeRegulatory Full time

Our organization seeks a seasoned Regulatory Affairs expert to spearhead global submissions and ensure compliance with regulatory requirements across international markets. The ideal candidate will possess in-depth knowledge of dossier formats, submission pathways, and lifecycle management.The selected individual will be responsible for:Authoring, compiling, and submitting regulatory dossiers to health authorities worldwide, including the USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and other relevant bodies.Conducting gap analysis to identify document and data gaps in all CTD modules (1–5).Converting and preparing dossiers in eCTD, ACTD, and CTD formats.Overseeing end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions (variations, renewals, withdrawals).Cordinating responses to health authority queries through cross-functional collaboration and data collation.Maintaining a strong command over CMC, clinical, non-clinical, and administrative documentation for successful global submissions.Project Planning & Management:Managing multiple product submissions across multiple countries simultaneously.Utilizing project management tools to track project milestones, timelines, and deliverables.Ensuring efficient time and resource allocation to meet submission deadlines.Fostering seamless communication between central regulatory, regional teams, and client stakeholders.Requirements:8–10 years of core Regulatory Affairs experience handling submissions across regulated and RoW markets.A deep understanding of global dossier formats, submission pathways, and lifecycle management.Excellent cross-functional communication and coordination skills.A proven ability to manage complex multi-country regulatory portfolios.This is an exceptional opportunity for an experienced Regulatory Affairs professional to take their career to the next level. If you are a motivated and results-driven individual with a passion for regulatory compliance, we encourage you to apply.

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