Regulatory Affairs Expert

2 weeks ago

nadiad, India beBeeExpertise Full time

Regulatory Affairs ExpertiseRegulatory Affairs SpecialistAs a seasoned regulatory affairs specialist, you will play a pivotal role in ensuring accurate, timely, and compliant global health authority submissions. The primary objective is to compile high-quality regulatory dossiers that meet the rigorous standards of various global health authorities.Key Responsibilities:Author and assemble comprehensive regulatory dossiers for global health authorities, including submission preparations and management.Conduct thorough dossier gap analysis and identify document and data gaps across all CTD modules (1–5).Prepare and submit ANDA, NDA, BLA, MAA, and other lifecycle submissions, overseeing end-to-end preparation and submission processes.Collaborate with cross-functional teams to respond to health authority queries and maintain accurate documentation.Essential Skills and Qualifications8–10 years of core experience in Regulatory Affairs, handling submissions across regulated and RoW markets.Strong understanding of global dossier formats, submission pathways, and lifecycle management.Excellent communication and coordination skills, with proven ability to manage complex multi-country regulatory portfolios.Requirements:A deep knowledge of global regulatory requirements and guidelines.The ability to work effectively in a fast-paced environment and adapt to changing priorities.Exceptional problem-solving skills, with the ability to analyze complex issues and develop effective solutions.

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