Senior Manager, Global Regulatory Affairs - LCM CMC

We are looking for a Senior Manager to join our Global Regulatory Affairs team, specializing in Lifecycle Management (LCM) for Chemistry, Manufacturing, and Controls (CMC). CMC ensures that pharmaceutical products are consistently produced and meet quality standards during development and throughout their lifecycle.

In this role, you will develop global regulatory strategies to support the lifecycle of biosimilar products. You’ll provide regulatory guidance, manage CMC documentation for variations, and collaborate with cross-functional teams to align strategies. Your work will involve assessing regulatory risks, interacting with health authorities, and ensuring compliance.

Key Responsibilities:

• Develop and implement global CMC regulatory strategies for lifecycle management of biosimilars
• Provide aligned CMC regulatory advice across cross-functional teams
• Identify and mitigate regulatory risks for CMC, escalating as necessary
• Manage CMC documentation for variation filings and respond to health authority queries
• Collaborate with external partners to ensure regulatory compliance and dossier alignment
• Participate in health authority interactions to support product approvals and maintenance

Qualifications:

• PhD with at least 3 years, MS with at least 5 years, or BS with at least 7 years of experience in relevant roles within the Pharmaceutical/Biotech industry
• Strong expertise in regulatory affairs, lifecycle management, and CMC activities
• Experience with variation filings in the US and EU markets
• Ability to work effectively in diverse, cross-functional teams
• Fluency in English; additional languages are a plus

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 are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.

True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.