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Open nowPosted 8 days ago

Manager, Regulatory LCM CMC-3

alvotech15 open roles

Where
India Home Office
Work mode
Remote
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Your applicationOpen nowManager, Regulatory LCM CMC-3alvotech · India Home Office

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The clock on this job

Early applications get read.

13.6% of postings close within 7 days. Measured by our own scanner across the market. alvotech postings stay open a median of 13 days.

Share of postings closed within
  1. 2.3%1 day
  2. 4.7%3 days
  3. 13.6%7 days
  4. 21.9%14 days
  5. 36.9%30 days
  6. 59.0%60 days
This job: posted 8 days ago

alvotech median: 13 days open

The posting

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
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