Manager, Regulatory LCM CMC-3

This position, Manager in Global Regulatory Affairs LCM CMC, is a project-facing CMC position supporting life-cycle management. Regulatory Execution - Prepare, review, and submit post-approval CMC regulatory filings, including: - Variations (Type IA/IB/II) - Supplements (PAS, CBE-30, CBE-0) - Annual reports and renewals - Ensure submissions meet regional requirements (FDA, EMA, and other global health authorities). - Track submission timelines and ensure on-time delivery. Change Management - Evaluate CMC changes (manufacturing, analytical, raw materials, etc.) for regulatory impact. - Support regulatory classification and filing strategy for change controls. - Work closely with cross-functional teams to ensure appropriate documentation. Lifecycle Management - Maintain and update Module 3 (CMC) sections of regulatory dossiers. - Support product lifecycle activities including label updates (CMC-related), site transfers, and process improvements. - Ensure compliance of existing licenses with updated regulatory requirements. Health Authority Interaction - Support preparation of responses to queries, deficiency letters, and information requests. - Assist in compiling documentation for regulatory inspections and audits. Cross-Functional Collaboration - Collaborate with Quality, Manufacturing, Supply Chain, and Technical Operations teams. - Participate in change control meetings and provide regulatory input. - Communicate regulatory requirements clearly to stakeholders. Competencies - Understanding of regional frameworks: - US FDA (BLA lifecycle, supplements categories) - EU EMA (Variation Regulation) - Japan PMDA requirements - Knowledge of biologics manufacturing processes: - Cell culture, upstream/downstream processing - Aseptic filling, sterility assurance - Understanding of: - Analytical methods & specifications - Process validation and control strategies - Familiarity with ICH guidelines (Q5E, Q6B, Q8–Q12) - Understanding of: - Supply chain implications of regulatory decisions Qualifications - PhD 1 - 3 years, MS 4 - 6 years, BS 6 - 8 years in relevant functions in the Pharmaceutical/Biotechnology Industry, or equivalent. - Subject matter expertise in regulatory affairs and related activities. - Previous experience in life cycle management activities with direct experience in variation filing for US, EU - Ability to work in a matrix, teams, and diverse cultures is essential - Fluency in English is essential, other languages are beneficial Originally posted on Himalayas