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