Global Regulatory Affairs Specialist

6 days ago

bhavnagar, India beBeeRegulatory Full time

Job DescriptionWe are seeking a skilled Regulatory Affairs Specialist to play a pivotal role in our global submissions team. The successful candidate will be responsible for managing the end-to-end preparation and submission of regulatory documents to health authorities worldwide.Key Responsibilities:Author and compile comprehensive regulatory dossiers for submission to global health authorities, including US FDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others.Conduct thorough 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.Project Planning & ManagementManage 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.This is an excellent opportunity to join a dynamic team and contribute to the success of our organization.

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    bhavnagar, India beBeeCompliance Full time

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    bhavnagar, India beBeeCompliance Full time

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    bhavnagar, India beBeeCompliance Full time

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    bhavnagar, India beBeePackaging Full time

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    bhavnagar, India beBeeDataRemediation Full time

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    bhavnagar, India beBeeDelivery Full time

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    bhavnagar, India beBeeRegulatory Full time

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    bhavnagar, India beBeeRadiation Full time

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    Bhavnagar, India Vvelox Global Business Advisory Full time

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    1 hour ago

    Bhavnagar, India ADANI GROUP Full time

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