Manager, Regulatory LCM CMC

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟢 Junior

🚔 Compliance

👻 Ghost score 15%

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Alvotech

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

💰 $78.3M Post IPO equity on 2025-07

Biotechnology • Pharmaceuticals • Healthcare

Alvotech is a biopharmaceutical company that specializes in developing and manufacturing biosimilars—biologic medicines highly similar to approved reference biologics—to increase global patient access to affordable biologic therapies. The company follows a vertically integrated approach, covering cell line development through fill-and-finish manufacturing, and partners with commercialization experts to bring products to market. Its pipeline includes proposed biosimilars to high-profile biologics, and it emphasizes scale, control and speed in production. Alvotech operates globally and focuses on improving access to biologic medicines.

📋 Description

• 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

• 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

• Fully remote work arrangement

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