Manager, Regulatory LCM CMC-3

Alvotech; India; À distance; INR 1 500 000 - 2 500 000; Plein temps

Résumé du poste

Alvotech in India is seeking a Manager in Global Regulatory Affairs LCM CMC to lead life-cycle management and regulatory execution for post-approval filings. You will navigate Variations, Supplements, Annual Reports, and ensure compliance with FDA, EMA, and other authorities.

The role requires close collaboration with QA, Manufacturing, Supply Chain, and Technical Operations to meet timelines. Expect strong knowledge of biologics manufacturing processes, ICH guidelines, and cross-cultural

Qualifications

• PhD with regulatory affairs experience in lifecycle management.
• MS with 4–6 years, BS with 6–8 years in pharma/biotech.
• Subject matter expertise in US FDA and EU EMA variations, and PMDA.

Responsabilités

• Prepare, review, and submit post-approval CMC regulatory filings including variations, supplements, and annual reports.
• Evaluate regulatory changes for impact and filing strategy across manufacturing, analytics, and materials.
• Maintain and update Module 3 (CMC) sections and lifecycle-related updates.
• Support regulatory inspections, responses to queries, and audit documentation.
• Collaborate with Quality, Manufacturing, Supply Chain, and Technical Operations to align regulatory submissions.
• Communicate regulatory requirements clearly to stakeholders.

Connaissances

Regulatory affairs

Lifecycle management

Cross-functional collaboration

English fluency

Regulatory strategy

Formation

PhD

MS

BS

Description du poste

This position, Manager in Global Regulatory Affairs LCM CMC, is a project-facing CMC position supporting life-cycle management.Regulatory ExecutionPrepare, review, and submit post-approval CMC regulatory filings, including:Variations (Type IA/IB/II)Supplements (PAS, CBE-30, CBE-0)Annual reports and renewalsEnsure submissions meet regional requirements (FDA, EMA, and other global health authorities).Track submission timelines and ensure on-time delivery.Change ManagementEvaluate 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 ManagementMaintain 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 InteractionSupport preparation of responses to queries, deficiency letters, and information requests.Assist in compiling documentation for regulatory inspections and audits.Cross-Functional CollaborationCollaborate with Quality, Manufacturing, Supply Chain, and Technical Operations teams.Participate in change control meetings and provide regulatory input.Communicate regulatory requirements clearly to stakeholders.CompetenciesUnderstanding of regional frameworks:US FDA (BLA lifecycle, supplements categories)EU EMA (Variation Regulation)Japan PMDA requirementsKnowledge of biologics manufacturing processes :Cell culture, upstream/downstream processingAseptic filling, sterility assuranceUnderstanding of:Analytical methods & specificationsProcess validation and control strategiesFamiliarity with ICH guidelines (Q5E, Q6B, Q8–Q12)Understanding of:Supply chain implications of regulatory decisionsQualificationsPhD 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, EUAbility to work in a matrix, teams, and diverse cultures is essentialFluency in English is essential, other languages are beneficial