Senior Regulatory Affairs Manager

4 days ago


sangli, India beBeeRegulatory Full time

Job Opportunity:Senior Regulatory Affairs Manager - US Market ExpansionThis position oversees the end-to-end preparation and submission of regulatory dossiers to the FDA, ensuring compliance with relevant guidelines and regulations. Key responsibilities include leading query responses, amendments, and post-approval submissions.The ideal candidate will possess a strong understanding of complex generics, including injectables and liquid dosage forms. Experience in preparing and submitting FDA meeting requests and packages is also essential.Strong leadership and team management skills are required to guide a team of regulatory professionals, providing guidance, training, and performance management. Effective communication with internal stakeholders and external regulatory bodies is crucial.Master's degree in Pharmacy or related fieldMinimum 13 years of experience in US Regulatory Affairs with proven track record in ANDA/NDA submissionsHands-on experience with FDA meetings, Controlled Correspondence, and post-approval changesStrong understanding of complex formulations and regulatory strategyExcellent written and verbal communication skillsDemonstrated leadership and team management capabilities



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