Alvotech is looking to hire a Manager for Global Regulatory Affairs Life-Cycle Management (LCM) Chemistry, Manufacturing, and Controls (CMC). In this role, you will support life-cycle management of biosimilar products by developing regulatory strategies, representing the CMC regulatory team in cross-departmental projects, and ensuring unified regulatory advice. You will also identify and mitigate regulatory risks, manage high-quality documentation, participate in health authority interactions, and collaborate with external partners.
Post : Manager, Global Regulatory Affairs LCM CMC
Job Description
• Assist in developing regulatory LCM CMC strategies.
• Represent CMC regulatory team in cross-functional teams.
• Communicate unified GRA-aligned messages at interdisciplinary meetings.
• Identify and mitigate product CMC regulatory risks.
• Assess and approve change controls for responsible products.
• Review and manage high-quality CMC documentation.
• Understand and apply ICH, FDA guidelines, GMP, and quality requirements.
• Participate in health authority interactions.
• Interface with external partners to support commercial success.
• Support development of regulatory excellence tools and processes.
• Ensure efficient and transparent working environment within GRA.
• Keep projects on track and within budget.
Candidate Profile
• 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 and variation filing for US, EU.
• Ability to work in matrix teams and diverse cultures.
• Ability to work effectively in a fast-paced dynamic environment.
• Fluency in English is essential; other languages are beneficial.
• An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
• The chance to be part of a global and fast-growing company.
• An international work culture that encourages diversity, collaboration, and inclusion.
• Positive, flexible, and innovative work environment.
• A clear and developed organizational structure.
• Training and global opportunities to advance.
• A good work-life balance.
• Home internet and home office equipment.
Additional Information
Experience & Qualification : PhD (1-3 years), MS (4-6 years), BS (6-8 years)
Location : India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs LCM CMC
End Date : April 13, 2025
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