Manager, Regulatory LCM CMC-3

About this role

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