Senior Manager, Regulatory LCM

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