Regulatory Labelling Manager

Role Overview

The Labelling Hub Manager is responsible for overseeing regulatory labelling activities for assigned countries or regions, ensuring that labelling updates are executed in accordance with applicable legislation, regulatory requirements, and internal procedures.

Acting as a regional labelling subject matter expert, the role provides strategic and operational support to global labelling leadership and cross-functional stakeholders on initiatives that impact labelling activities within the designated region. The position plays a key role in driving consistency, compliance, and timely delivery of labelling updates across multiple markets.

Key Responsibilities

• Serve as the primary point of contact for global labelling teams for assigned countries and product licenses

• Oversee and report on agreed key performance indicators for the assigned region

• Onboard, manage, and provide day-to-day oversight to regionally assigned labelling associates

• Communicate issues, risks, and resolutions clearly and effectively to peers and team members

• Ensure local labelling texts are prepared accurately and delivered on time in accordance with internal procedures and agreed objectives

• Support regional labelling team members in responding to health authority questions, requests for information, and the preparation and review of labelling documents prior to submission

• Escalate and advise global labelling leadership on labelling-related risks, gaps, or compliance concerns

• Ensure availability and timely distribution of reference labelling documents (e.g., Core Data Sheets, SmPC, USPI, or equivalent) in line with local regulatory requirements

• Coordinate the preparation and maintenance of local labelling texts above-market on behalf of impacted countries to ensure alignment with internal standards and local legislation

• Manage labelling variations within Regulatory Information Management (RIM) and change-control systems to demonstrate compliance with global submission timelines and documented justifications for delays

• Liaise with translation vendors to ensure high-quality and compliant translations

• Apply working knowledge of artwork development processes and interfaces with launch management, supply chain, and quality teams

• Ensure accurate maintenance of labelling records and systems in accordance with applicable SOPs

Skills & Experience

• Bachelor's degree in Science, Medicine, Pharmacy, or a related discipline; advanced degree preferred

• Demonstrated experience in regulatory affairs and product labelling

• Experience working with regional health authorities and strong knowledge of regional labelling requirements

• Excellent interpersonal, presentation, and communication skills, including advanced proficiency in the local language(s)

• Ability to propose innovative, compliant labelling solutions that align with organizational objectives

• Strong understanding of global labelling governance frameworks and EU and/or US regulatory requirements

• Proven ability to influence and collaborate effectively in a matrixed, cross-functional environment