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Alvotech

Senior Manager, Regulatory LCM

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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

Originally posted on Himalayas