Senior Compliance Specialist

1 week ago

nashik, India beBeeRegulatory Full time

Regulatory Affairs SpecialistThis role involves preparing and submitting regulatory dossiers to global health authorities. Key responsibilities include authoring, compiling, and converting dossiers in multiple formats, as well as managing end-to-end preparation and submission of lifecycle submissions.Project Planning & Management:Manage regulatory submissions for multiple products across various countries simultaneously.Utilize project management tools to track project milestones and deliverables.Ensure efficient time and resource allocation to meet submission deadlines.Requirements:8–10 years of experience in Regulatory Affairs with a strong understanding of global dossier formats and submission pathways.Excellent cross-functional communication skills and proven ability to manage complex regulatory portfolios.Key Skills:Strong command over CMC, clinical, non-clinical, and administrative documentation.Ability to conduct dossier gap analysis and identify document and data gaps across all CTD modules.

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    nashik, India beBeeCompliance Full time

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    nashik, India beBeeCompliance Full time

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    nashik, India beBeeCompliance Full time

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    nashik, India beBeecompliance Full time

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    nashik, India beBeeOperations Full time

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    nashik, India beBeeDatabase Full time

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    nashik, India beBeeRegulatory Full time

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    nashik, India beBeeProjectManagement Full time

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    nashik, India beBeeManualTesting Full time

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