Global Regulatory Compliance Expert

2 weeks ago

mumbai, India beBeeRegulatory Full time

Regulatory Affairs SpecialistJob OverviewThe Regulatory Affairs Specialist will be responsible for overseeing the regulatory submission process for multiple products across various countries simultaneously. This involves coordinating, compiling, and submitting comprehensive regulatory dossiers to global health authorities.Key responsibilities include:Ensuring accurate compilation and submission of regulatory dossiers.Conducting thorough dossier gap analysis to identify document and data gaps.Managing the entire lifecycle preparation and submission of ANDA, NDA, BLA, MAA, and other regulatory submissions.Required Skills and QualificationsThis role requires strong analytical skills, excellent communication, and coordination abilities. The ideal candidate should possess a solid understanding of global dossier formats, submission pathways, and lifecycle management.What We OfferWe strive to provide a supportive work environment that fosters growth and development. As a Regulatory Affairs Specialist, you can expect to work in a dynamic team that values collaboration and open communication.

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