Manager, Regulatory LCM CMC-3

IN10 Alvotech Biosciences India PVT Ltd; India; Remote; INR 2.500.000 - 4.000.000; Vollzeit

Zusammenfassung

Alvotech is seeking a Manager in Global Regulatory Affairs LCM CMC to lead post-approval CMC filings, manage regulatory timelines, and coordinate across Quality, Manufacturing, Supply Chain, and Technical Operations.

You will drive lifecycle activities, document updates, and regulatory interactions with FDA/EMA, aiming to ensure compliant submissions and timely licenses across regions.

Qualifikationen

• PhD/MS/BS with regulatory lifecycle exp in pharma/biotech
• Experience with US/EU variation filings preferred
• English fluency required; other languages beneficial

Aufgaben

• Prepare, review, and submit post-approval CMC regulatory filings (Variations, Supplements, Annual reports)
• Ensure submissions meet FDA/EMA and global health authority requirements
• Track timelines and ensure on-time delivery of submissions
• Evaluate regulatory impact of CMC changes and filing strategy
• Update Module 3 sections and support lifecycle activities (label, site transfers)

Kenntnisse

Regulatory affairs

Global filings

Lifecycle management

English fluency

Cross-functional collaboration

Ausbildung

PhD

MS

BS

Tools

Regulatory submissions software

Jobbeschreibung

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

At Alvotech, we are building a global biotechnology company with a clear purpose: to expand access to high‑quality, affordable biologic medicines for patients worldwide. Our people are central to that mission.

Across our global teams, we bring together expertise in science, manufacturing, quality and commercial operations to shape the future of biosimilars. We offer a dynamic, fast-moving environment where curiosity, initiative and ownership are encouraged.

Rooted in Icelandic values and operating on a global stage, we value collaboration, diversity and integrity across everything we do. Our teams work on meaningful challenges, contribute directly to patient impact, and grow alongside the business.

Whether you are at the start of your career or looking to take your next step, Alvotech offers the opportunity to do work that matters, in a company driven by purpose and scale.

If you have any technical issues, please contact: [e-mail]