Core Labeling Lead

We are looking for an experienced Core Labeling Lead (CLL) to join Alvotech and take a leading role in the development, oversight, and implementation of labeling strategy for our biosimilar portfolio.

In this role, you will act as the regulatory labeling expert for US and EU markets, supporting products across development and commercialization. You will work closely with global cross‑functional stakeholders, provide strategic guidance to Regulatory Labeling Leads, and support the Head of Regulatory Labeling while operating with a high degree of autonomy.

This is an opportunity to make a meaningful impact in a fast‑growing global biotech company where quality, collaboration, and innovation are key drivers.

Scope and Responsibilities

• Act as the Regulatory Labeling subject‑matter expert for US and EU labeling, advising on authority requirements, internal processes, and standards

• Lead, author, review, and compile regional and country labeling in line with regulatory expectations and Alvotech standards

• Drive and monitor labeling deliverables in alignment with project timelines and priorities

• Facilitate and chair key labeling meetings with global, cross‑functional stakeholders

• Ensure quality, accuracy, consistency, formatting, and regional alignment of labeling documents

• Act as Change Action Owner for labeling text and artwork

• Coordinate and manage labeling documentation and data in regulatory systems

• Support Global Regulatory Affairs and Product Teams with additional labeling documentation as required

• Contribute to labeling process improvements and the evaluation of new regulatory requirements

• Line manage and support Regulatory Labeling Leads (RLLs), fostering collaboration and development

Job Requirements

• Bachelor’s degree in a relevant field and 5+ years of experience in regulatory labeling within the pharmaceutical or life sciences industry

• Strong experience with USPI authoring and EU MAA submissions, including EU mock‑ups and Readability User Testing

• Solid knowledge of labeling regulations across multiple regions

• Experience with document management, change control processes, and regulatory systems such as Veeva RIM / Veeva Quality

• Strong communication and stakeholder‑management skills, with the ability to work independently in a global environment

• Fluency in English (written and spoken)

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.