Regulatory Labeling Mgr

Overview

Career Category

Regulatory

Job Description

Overview

Regulatory Labeling Manager will support the planning, coordination, and execution of EU and global labelling compliance activities within the Regulatory Affairs organisation. This role will support end-to-end labelling activities, including Product Information updates, linguistic review, mock-up coordination, artwork review, approval workflows, and implementation of approved labelling changes.

Working in a fast-paced, matrixed environment with no direct reports, the role will collaborate closely with global, regional, and local Regulatory Affairs teams, Quality, Operations, Supply Chain, affiliates, and external vendors. The position requires strong attention to detail, effective stakeholder management, and the ability to coordinate multiple labelling deliverables across markets, timelines, and functions.

This role provides an opportunity to contribute to EU labelling activities, support inspection readiness, strengthen labelling processes, and ensure that Product Information, packaging components, and artwork are maintained in accordance with applicable regulatory requirements, approved Marketing Authorisations, and internal quality standards.

Key Responsibilities

• Labelling Compliance and Change Management
• EU Labelling Process and Product Information Coordination
• Linguistic Review Coordination
• Artwork Review, Approval, and Implementation
• Cross-functional and Vendor Coordination

Coordinate day-to-day labelling activities to support timely and compliant implementation of approved labelling changes across EU and global markets.

Manage labelling change requests, track deliverables, monitor timelines, and maintain accurate records in applicable labelling, artwork, or document management systems.

Serve as an operational point of contact for labelling activities, providing guidance to internal stakeholders on labelling processes, document requirements, formats, and timelines.

Ensure labelling updates are aligned with approved Product Information, internal procedures, quality standards, and market-specific implementation requirements.

Identify potential compliance risks, delays, inconsistencies, or documentation gaps and escalate issues to the appropriate stakeholders for timely resolution.

Support EU labelling activities across applicable procedures, including centralised, decentralised, mutual recognition, and national procedures, as relevant.

Coordinate updates to EU Product Information components, including the Summary of Product Characteristics, Package Leaflet, outer labelling, inner labelling, mock-ups, and related packaging text.

Support alignment of labelling content with approved Marketing Authorisations, regulatory commitments, internal procedures, and country-specific requirements.

Coordinate with regional and local Regulatory Affairs contacts to gather requirements, clarify expectations, resolve queries, and support implementation of approved labelling changes.

Track EU labelling milestones, review comments, approvals, and implementation status to ensure visibility across stakeholders and support delivery against agreed timelines.

Facilitate linguistic review activities for EU labelling updates, working with affiliates, local regulatory contacts, translation vendors, and internal reviewers.

Coordinate the review of country-specific translations to support consistency, accuracy, and alignment with approved source Product Information.

Track linguistic review comments, queries, responses, and approvals to ensure timely completion of country-specific labelling requirements.

Support resolution of translation queries, terminology discrepancies, formatting issues, and Member State or local affiliate comments in partnership with relevant stakeholders.

Maintain accurate documentation of linguistic review activities, decisions, approvals, and final approved local texts in applicable systems.

Coordinate artwork review and approval workflows to ensure packaging components accurately reflect approved labelling text, technical requirements, and market-specific information.

Support review of artwork components, including cartons, labels, leaflets, blisters, foils, and other printed packaging materials, as applicable.

Collaborate with artwork vendors, Regulatory Affairs, Quality, Supply Chain, Operations, and local affiliates to support timely artwork creation, review, approval, release, and implementation.

Review artwork-related documentation for completeness, consistency, version control, and alignment with approved Product Information and internal procedures.

Monitor artwork timelines and proactively follow up with stakeholders to address delays, open comments, approval bottlenecks, or implementation risks.

Maintain accurate records of artwork decisions, review comments, approvals, version history, and implementation evidence in relevant systems.

Partner with global, regional, and local stakeholders across Regulatory Affairs, Quality, Operations,