Manager, Regulatory LCM CMC-3

This position, Manager in Global Regulatory Affairs LCM CMC, is a project-facing CMC position supporting life-cycle management.

Responsibilities

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; 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; 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; Support preparation of responses to queries, deficiency letters, and information requests; Assist in compiling documentation for regulatory inspections and audits; 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

Requirements

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; 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

Nice to have

Other languages are beneficial