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
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