Overview The Manager, Regulatory Affairs – CMC leads all CMC regulatory activities for ANDAs, supplements, and amendments. This role involves authoring and reviewing submissions, assessing change controls, coordinating cross-functional teams, interacting with regulatory agencies, and guiding the regulatory affairs team. The position ensures high-quality, compliant submissions that support the company’s product portfolio. Responsibilities Leading preparation and review of CMC sections for ANDAs, supplements, and amendments Reviewing technical data and providing regulatory/scientific assessments Evaluating change controls, deviations, and post-approval changes Coordinating with Quality, Manufacturing, Analytical Development, and R&D teams Monitoring regulatory guidelines and agency expectations Developing SOPs and best practices for submissions and change control Participating in audits and training activities Ensuring timely responses to regulatory agency queries Determining reporting categories for CMC changes Preparing and submitting post-approval documents (Annual Reports, CBE-0, CBE-30, PAS) Managing amendments, notifications, and lifecycle submissions Supporting site transfers, process and specification changes, validations, equipment and packaging updates Maintaining regulatory records, databases, version control, and document archiving Promoting continuous improvement, compliance, and knowledge sharing Qualifications Master’s degree in pharmacy, chemistry, pharmaceutical sciences, or related field; advanced degree preferred 4-6 years of experience in regulatory affairs focusing on CMC for ANDAs, supplements, and amendments in the pharmaceutical industry Proven experience in authoring, reviewing, and managing CMC sections for regulator submissions Strong knowledge of FDA and global regulatory requirements for generics, supplements, and post-approval changes Demonstrated team leadership skills, including mentoring, coaching, and managing regulatory affairs professionals Excellent cross-functional collaboration, analytical, and problem-solving skills Strong written and verbal communication skills for drafting regulatory documents and interacting with agencies Ability to manage multiple projects, prioritize tasks, and meet deadlines in a fast-paced environment Competencies Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility #J-18808-Ljbffr Lupin Pharmaceuticals
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