This position, Senior Manager in Global Regulatory Affairs LCM-CMC, is a project-facing CMC position supporting life-cycle management.
Key Responsibilities
Regulatory Strategy & Execution
Develop and implement global regulatory strategies for post-approval CMC changes.
Assess regulatory impact of manufacturing, process, analytical, and supplier changes.
Provide strategic CMC regulatory guidance to cross-functional teams (Quality, Manufacturing, Supply Chain, Analytical Development).
Submission Management
Author, review, and manage submission of post-approval regulatory filings, including:Variations (Type IA/IB/II)
Supplements (PAS, CBE-30, CBE-0)
Annual reports
Renewals and line extensions
Ensure alignment with regional requirements (FDA, EMA, & PMDA)
Coordinate timely submission and approval of regulatory documents.
Lifecycle Management
Manage change control assessments and regulatory categorization.
Maintain regulatory dossiers (Module 3) in line with current regulatory expectations.
Health Authority Interactions
Serve as a key contact for CMC-related queries from health authorities.
Prepare responses to regulatory questions and deficiency letters.
Cross-Functional & External Collaboration
· Partner with MSAT, ARD, Pharm-Sci, Quality Assurance, Supply Chain, and Commercial
· Participate in change review boards and governance bodies.
· Provide regulatory input on product supply continuity strategies
· Interface and represent GRA with/to external partners to ensure global dossier alignment and support supply and enable the commercial success
Competencies
Ability to develop global regulatory strategies for post-approval CMC changes
In-depth understanding of regional frameworks:US FDA (BLA lifecycle, supplements categories)
EU EMA (Variation Regulation)
Japan PMDA requirements
Capability to balance compliance, speed, and business needs (e.g., supply continuity)
Skilled in risk-based decision-making and regulatory scenario analysis
Strong knowledge of biologics manufacturing processes:Cell culture, upstream/downstream processing
Aseptic filling, sterility assurance
Understanding of:Analytical methods & specifications
Process validation and control strategies
Expertise in comparability principles (ICH Q5E)
Familiarity with ICH guidelines (Q5E, Q6B, Q8–Q12)
Understanding of:Supply chain implications of regulatory decisions
Commercial priorities and market needs
Ability to align regulatory strategy with business continuity and product lifecycle value
Qualifications:
PhD 3+ years, MS 5+ years, BS 7+ years in relevant functions in the Pharmaceutical/Biotechnology Industry, or equivalent.
Previous experience in life cycle management activities with direct experience in variation filing for US, EU & Japan
Subject matter expertise in regulatory affairs and related activities.
Proven ability to produce high-quality CMC documentation for complex large molecules
Ability to work in a matrix, teams, and diverse cultures is essential
Fluency in English is essential