Manager, Regulatory LCM CMC

Alvotech

. Prepare, review, and submit post-approval CMC regulatory filings, including Type IA/IB/II variations, PAS, CBE-30, CBE-0 supplements, annual reports, and renewals .

Posted 10/31/2026full-timeRemote • IndiaJuniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs with a focus on CMC regulatory filings, lifecycle management, and compliance with FDA and EMA requirements. Proficient in collaborating with cross-functional teams to ensure timely and accurate submissions while maintaining adherence to industry guidelines.

Highest-signal resume keywords

Regulatory Affairs ExpertiseCMC Regulatory FilingsLifecycle Management ActivitiesKnowledge of FDA and EMA RegulationsBiologics Manufacturing Processes

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CMC Regulatory FilingsLifecycle ManagementRegulatory Submission PreparationAnalytical Methods UnderstandingProcess ValidationAseptic Filling KnowledgeRegulatory ComplianceChange Control StrategyModule 3 CMC Sections MaintenanceRegulatory Inspection Documentation

Soft Skills

CollaborationCommunicationMatrix TeamworkStakeholder EngagementCultural Adaptability

Industry Keywords

Pharmaceutical IndustryBiotechnology IndustryFDAEMAICH GuidelinesJapan PMDABiologicsCell CultureUpstream ProcessingDownstream Processing

About the role

Key responsibilities & impact

Prepare, review, and submit post-approval CMC regulatory filings, including Type IA/IB/II variations, PAS, CBE-30, CBE-0 supplements, annual reports, and renewals
Ensure submissions meet regional requirements of the FDA, EMA, and other global health authorities
Track submission timelines and ensure on-time delivery
Evaluate CMC changes involving manufacturing, analytical methods, raw materials, and other areas for regulatory impact
Support regulatory classification and filing strategy for change controls
Collaborate with cross-functional teams to ensure appropriate documentation
Maintain and update Module 3 CMC sections of regulatory dossiers
Support lifecycle activities including CMC-related label updates, site transfers, and process improvements
Ensure existing licenses comply with updated regulatory requirements
Support preparation of responses to queries, deficiency letters, and information requests
Assist in compiling documentation for regulatory inspections and audits
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

Requirements

What you’ll need

PhD with 1–3 years of experience, MS with 4–6 years, BS with 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 and EU
Understanding of US FDA BLA lifecycle and supplements categories
Understanding of EU EMA Variation Regulation
Knowledge of Japan PMDA requirements
Knowledge of biologics manufacturing processes, including cell culture and upstream/downstream processing
Knowledge of aseptic filling and sterility assurance
Understanding of analytical methods and specifications
Understanding of process validation and control strategies
Familiarity with ICH guidelines (Q5E, Q6B, Q8–Q12)
Understanding of supply chain implications of regulatory decisions
Ability to work in a matrix, teams, and diverse cultures
Fluency in English; other languages are beneficial

Benefits

Comp & perks

Fully remote work arrangement