Strategic Regulatory Compliance Manager

2 weeks ago


nagpur, India beBeeRegulatoryAffairs Full time

Job Description: As a Regulatory Affairs Specialist, you will play a crucial role in ensuring the smooth submission of regulatory dossiers to global health authorities. Your key responsibilities include authoring, compiling, and submitting these dossiers to various organizations such as USFDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and others.Key Responsibilities:Conduct dossier gap analysis to identify document and data gaps across all CTD modules (1–5)Convert and prepare dossiers in multiple formats including eCTD, ACTD, and CTDManage end-to-end preparation and submission of ANDA, NDA, BLA, MAA, and other lifecycle submissions (variations, renewals, withdrawals)Requirements: You will need excellent project management skills to track project milestones, timelines, and deliverables. Additionally, you should be able to ensure efficient time and resource allocation to meet submission deadlines while fostering seamless communication between central regulatory, regional teams, and client stakeholders.Benefits: This role offers an opportunity to work on high-profile projects and contribute to the growth and success of the organization.What We Offer: A dynamic and supportive work environment, opportunities for professional development, and a competitive compensation package.



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