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AI Summary
Manage post-approval CMC regulatory filings and evaluate the regulatory impact of manufacturing changes. Collaborate with cross-functional teams to maintain regulatory dossiers and respond to health authority queries.
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
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