Global Regulatory Submission Specialist

15 hours ago

thane, India beBeeCompliance Full time

Regulatory Compliance ExpertWe are seeking a seasoned Regulatory Affairs Specialist to join our team.Description:This role is responsible for ensuring regulatory compliance for clients by managing and submitting regulatory dossiers. It involves working closely with cross-functional teams to gather necessary data and information.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 (1–5).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 (variations, renewals, 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.Project Planning & Management:Manage 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.Foster seamless communication between central regulatory, regional teams, and client stakeholders.Requirements:8–10 years of core experience in Regulatory Affairs, handling submissions across regulated and 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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