Regulatory Labeling Business Operational Associate

We are looking for a detail-oriented Regulatory Labeling – Business Operational Associate to support regulatory labeling implementation and lifecycle management activities.

In this role, you will support the Regulatory Implementation Labeling Lead with proofreading, formatting, quality control checks, and documentation management related to labeling text and artwork. You will work with text comparison tools, Microsoft applications, and Alvotech’s Regulatory Information Management Systems to ensure accurate, well-controlled, and compliant labeling documentation.

The role may also involve supporting data migration projects, tracker maintenance, and other operational activities within Regulatory Labeling.

Scope and Responsibilities

• Perform quality control checks and proofreading tasks related to labeling text and artwork.

• Support labeling development and lifecycle management activities using text comparison software.

• Generate labeling comparison reports using Microsoft Word and other relevant tools.

• Review and verify labeling documents using text-vs-text verification software such as Global Vision, Verify, or similar.

• Provide proofreading verdicts in Vault RIM upon request from the Regulatory Implementation Labeling Lead, Regulatory Labeling Lead, Core Labeling Lead, or Head of Regulatory Labeling.

• Ensure good documentation management of labeling components within Alvotech Veeva RIM systems.

• Support maintenance of trackers and operational tools related to labeling implementation and lifecycle management.

• Assist with data migration projects as needed.

• Escalate concerns or issues to senior management in a timely and appropriate manner.

• Work in accordance with applicable job descriptions, SOPs, company policies, and procedures available on the Alvotech intranet.

• Complete assigned departmental training conscientiously and efficiently.

• Contribute to a positive departmental culture that supports innovation, collaboration, and an entrepreneurial mindset.

Job Requirements

• At least 2 years’ experience in a relevant regulatory, labeling, quality, documentation, or operational role.

• Experience with software related to labeling creation, proofreading, text comparison, and document review.

• Experience using text-vs-text verification software such as Global Vision, Verify, or similar.

• Strong proficiency in Microsoft applications, particularly Word and Excel.

• Experience with Veeva Vault modules for Regulatory Information Management.

• Experience with change control management is considered an advantage.

• Strong attention to detail and ability to identify inconsistencies in text and formatting.

• Good documentation management skills and understanding of controlled document processes.

• Good time management skills with the ability to handle multiple tasks and manage several projects within predefined timelines.

• Ability to use good judgment and escalate issues when appropriate.

• Readiness to work outside designated office hours when needed.

• Fluency in English, both written and spoken.