Global Regulatory Affairs Manager

5 days ago

Kolhapur, India beBeeRegulatoryAffairs Full time

Job Overview:We are seeking a skilled Regulatory Affairs Specialist to manage global submissions for multiple products across various countries.Key Responsibilities:Submission Management: Author, compile, and submit regulatory dossiers to international health authorities, including the US FDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others.Dossier Gap Analysis: Conduct thorough reviews to identify document and data gaps across all CTD modules (1–5).Document Preparation: Convert and prepare dossiers in multiple formats, including eCTD, ACTD, and CTD.Lifecycle Submissions: Manage end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions, such as variations, renewals, and withdrawals.Cross-Functional Collaboration: Coordinate responses to health authority queries through effective collaboration and data collation.Documentation Expertise: Maintain a strong command over CMC, clinical, non-clinical, and administrative documentation to ensure successful global submissions.Requirements:Regulatory Experience: Proven experience in managing regulatory submissions, dossier gap analysis, and document preparation.Knowledge and Skills: Strong understanding of global health authorities, CTD modules, and regulatory documentation formats.Collaboration and Communication: Excellent communication and collaboration skills to work effectively with cross-functional teams.Benefits:Opportunity to Work: Join our dynamic team and contribute to the success of global regulatory submissions.Professional Growth: Develop your expertise in regulatory affairs and advance your career in a fast-paced environment.

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