Manager, Regulatory LCM CMC-3

Alvotech; United States; A distancia; USD 150.000 - 210.000; Jornada completa

Descripción de la vacante

Alvotech is seeking a Manager in Global Regulatory Affairs LCM CMC to lead lifecycle management and post-approval CMC submissions. The role focuses on coordinating with Quality, Manufacturing, and Supply Chain to ensure compliant, timely regulatory deliverables across US, EU, and other regions.

The position requires deep knowledge of regulatory frameworks (FDA/EMA/PMDA), strong cross-functional collaboration, and English fluency.

Formación

• Subject matter expertise in regulatory affairs.
• Ability to work in a matrix organization across cultures.
• Fluency in English is essential.
• Knowledge of US FDA, EU EMA, Japan PMDA frameworks.

Responsabilidades

• Prepare, review, and submit post-approval CMC regulatory filings (Variations, Supplements, Annual reports).
• Ensure submissions meet regional requirements (FDA, EMA, and other global health authorities).
• Track submission timelines and ensure on-time delivery.
• Evaluate CMC changes for regulatory impact and filing strategy.
• Maintain and update Module 3 (CMC) sections of regulatory dossiers; support lifecycle activities.
• Prepare responses to queries, deficiency letters, and information requests; assist regulatory inspections and audits.
• Collaborate with Quality, Manufacturing, Supply Chain, and Technical Operations; provide regulatory input in change control meetings.

Conocimientos

Regulatory affairs

FDA/EMA/PMDA knowledge

Cross-functional collaboration

English fluency

Educación

PhD

MS

BS

Descripción del empleo

This position, Manager in Global Regulatory Affairs LCM CMC, is a project-facing CMC position supporting life-cycle management.

Regulatory Execution

• Prepare, review, and submit post-approval CMC regulatory filings, including:
  • Variations (Type IA/IB/II)
  • Supplements (PAS, CBE-30, CBE-0)
  • Annual reports and renewals
• Ensure submissions meet regional requirements (FDA, EMA, and other global health authorities).
• Track submission timelines and ensure on-time delivery.

Change Management

• Evaluate CMC changes (manufacturing, analytical, raw materials, etc.) for regulatory impact.
• Support regulatory classification and filing strategy for change controls.
• Work closely with cross-functional teams to ensure appropriate documentation.

Lifecycle Management

• Maintain and update Module 3 (CMC) sections of regulatory dossiers.
• Support product lifecycle activities including label updates (CMC-related), site transfers, and process improvements.
• Ensure compliance of existing licenses with updated regulatory requirements.

Health Authority Interaction

• Support preparation of responses to queries, deficiency letters, and information requests.
• Assist in compiling documentation for regulatory inspections and audits.

Cross-Functional Collaboration

• Collaborate with Quality, Manufacturing, Supply Chain, and Technical Operations teams.
• Participate in change control meetings and provide regulatory input.
• Communicate regulatory requirements clearly to stakeholders.

Competencies

• Understanding of regional frameworks:
  • US FDA (BLA lifecycle, supplements categories)
  • EU EMA (Variation Regulation)
  • Japan PMDA requirements
• Knowledge of biologics manufacturing processes :
  • Cell culture, upstream/downstream processing
  • Aseptic filling, sterility assurance
• Understanding of:
  • Analytical methods & specifications
  • Process validation and control strategies
• Familiarity with ICH guidelines (Q5E, Q6B, Q8-Q12)
• Understanding of:
• Supply chain implications of regulatory decisions

Qualifications

• PhD 1 - 3 years, MS 4 - 6 years, BS 6 - 8 years in relevant functions in the Pharmaceutical/Biotechnology Industry, or equivalent.
• Subject matter expertise in regulatory affairs and related activities.
• Previous experience in life cycle management activities with direct experience in variation filing for US, EU
• Ability to work in a matrix, teams, and diverse cultures is essential
• Fluency in English is essential, other languages are beneficial