Job Opportunities API

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