Regulatory Compliance Manager

2 days ago

ghaziabad, India beBeeRegulatory Full time

Job Title: Regulatory Affairs SpecialistThe primary objective of this role is to ensure compliance with global health authorities' regulations. Key responsibilities include drafting and submitting regulatory dossiers, conducting gap analysis, managing submission preparation, and coordinating responses to queries.Draft, compile, and submit regulatory dossiers to global health authorities in compliance with all applicable regulations.Conduct thorough dossier gap analysis to identify document and data gaps that may impact regulatory submissions.Prepare and format dossiers in multiple formats for seamless submission.Manage the end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions across multiple countries.Cross-functional collaboration is essential in coordinating responses to health authority queries.Project Management & CoordinationOversee regulatory submissions for multiple products across various regions.Utilize project management tools to track project milestones, timelines, and deliverables for efficient time and resource allocation.Ensure timely submission deadlines are met by fostering effective communication between central regulatory teams, regional stakeholders, and client representatives.Requirements:A minimum of 8–10 years of core experience in Regulatory Affairs is required.A strong understanding of global dossier formats, submission pathways, and lifecycle management is necessary.Excellent cross-functional communication and coordination skills are essential for success.A proven ability to manage complex multi-country regulatory portfolios is crucial.Benefits: As a Regulatory Affairs Specialist, you will have the opportunity to work on diverse projects, develop your skills, and advance your career in a dynamic environment.

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