Regulatory Implementation Labeling Lead

We are looking for a skilled and detail‑oriented Regulatory Implementation Labeling Lead (RIL) to join Alvotech and support the lifecycle management of commercial labeling where Alvotech acts as Marketing Authorization Holder (MAH).

In this role, you will play a critical part in the implementation of labeling components at launch and during post‑approval changes, ensuring compliance, quality, and accuracy across global markets. You will work closely with the Head of Regulatory Labeling, lead change controls for labeling text and artwork, and ensure robust documentation and quality practices within Alvotech’s regulatory systems.

This role offers the opportunity to work at the intersection of regulatory compliance, operational excellence, and cross‑functional collaboration in a fast‑paced global biotech environment.

Scope and Responsibilities

• Own and manage Change Controls for labeling text and artwork for commercial products where Alvotech is MAH

• Lead labeling implementation for launch materials and revisions to commercial labeling components, primarily for the US market

• Ensure Good Documentation Practice (GDP), version control, and accurate labeling documentation within regulatory systems

• Perform and/or oversee Quality Control and proof‑reading activities for all labeling deliverables

• Independently manage labeling development projects for submissions to EU Notified Bodies, FDA DMEPA, and EMA (MAA and line extensions)

• Advise labeling colleagues and project teams on best practices for labeling content, consistency, and compliance

• Apply strong knowledge of FDA and EMA regulations, guidance, and labeling standards to support business needs

• Represent Regulatory Labeling in cross‑functional project team meetings

• Build and maintain strong relationships with internal and external stakeholders

• Manage the Regulatory Labeling Business Operational Associate (BOA)

• Use and maintain regulatory systems and tools, including Veeva Vault and text comparison software

• Support other regulatory activities and contribute to process improvements and new regulatory requirement evaluations

Job Requirements

• Bachelor’s degree and 6+ years of experience in a regulatory labeling role within the pharmaceutical or life sciences industry

• Strong hands‑on experience with commercial labeling implementation and life cycle management

• Solid knowledge of FDA and EMA labeling regulations and standards, including Structured Product Labeling (SPL)

• Experience with labeling tools and systems, including Veeva Vault, change control workflows, and text comparison software (e.g. GlobalVision, Verify)

• Proven ability to manage multiple labeling projects and priorities within tight timelines

• Strong attention to detail with a quality‑driven mindset

• Confident communicator with experience working across global, cross‑functional teams

• Comfortable working in a matrix environment and adapting to diverse cultures

• Fluency in English (written and spoken); flexibility to support activities outside regular office hours when required

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.