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

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