Manager, Global Regulatory Affairs at Alvotech | Apply Now
Looking for a meaningful career in biologics? Alvotech, a global leader in affordable biologic medicines, is hiring a Manager for Global Regulatory Affairs, LCM CMC. Be part of a purpose-driven organization that promotes inclusivity, innovation, and collaboration. If you’re passionate about transforming lives through affordable healthcare, this is your chance to contribute!
Welcome to Alvotech
Alvotech is passionate about improving lives by increasing access to affordable biologics. Committed to fostering an inclusive and diverse working environment, we encourage curiosity, ingenuity, and simplicity. Our purpose-driven approach aims to inspire employees in their careers, offering challenging and meaningful work opportunities in an innovative, agile setting.
Manager, Global Regulatory Affairs LCM CMC India – Full time
Deadline: April 13, 2025
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.
Key Responsibilities as Manager, Global Regulatory Affairs
- Assist in developing regulatory LCM CMC strategies.
- Represent the 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 the development of regulatory excellence tools and processes.
- Ensure an efficient and transparent working environment within GRA.
- Keep projects on track and within budget.
Job Requirements for Manager, Global Regulatory Affairs
- 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 the US and 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.
What we offer
- 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.
Why Alvotech?
At Alvotech, we believe in integrity, gender equality, and fairness. Join us in creating a healthier world through affordable biologic medicines by bringing together bright minds regardless of backgrounds and beliefs. Let’s collaborate to deliver to our partners and patients worldwide.
Keywords: Alvotech, Manager, Global Regulatory Affairs, Job Posting, LCM CMC, biologics, regulatory strategies, life-cycle management, biosimilar products
