Job description
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