Global Regulatory Affairs Expert

2 weeks ago


solapur, India beBeeRegulatoryAffairs Full time

Regulatory Affairs ProfessionalKey Responsibilities:Achieve regulatory compliance through effective submission and dossier management.Conduct gap analysis to identify document and data gaps in submissions.Prepare and submit regulatory dossiers in various formats, ensuring timely delivery.Oversee the preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions.Cultivate cross-functional collaboration to respond to health authority queries effectively.Maintain control over CMC, clinical, non-clinical, and administrative documentation.Project Management:Coordinate multiple product submissions across countries simultaneously, utilizing project management tools to track milestones.Ensure efficient allocation of resources and time to meet deadlines.Foster seamless communication among central regulatory teams, regional teams, and client stakeholders.Requirements:8–10 years of experience in Regulatory Affairs handling submissions globally.Thorough 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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