Regulatory Labeling Manager
Amgen
Regulatory Labeling Manager
Amgen
Makes biotech medicines for serious illnesses
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
1. Labelling Compliance and Change Management
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.
2. EU Labelling Process and Product Information Coordination
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.
3. Linguistic Review Coordination
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.
4. Artwork Review, Approval, and Implementation
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.
5. Cross-functional and Vendor Coordination
Partner with global, regional, and local stakeholders across Regulatory Affairs, Quality, Operations, Supply Chain, and affiliates to support compliant and timely labelling implementation.
Coordinate with external vendors, including translation providers and artwork vendors, to ensure deliverables meet agreed quality expectations, timelines, and service-level requirements.
Assist in monitoring vendor performance, identifying service gaps, and escalating issues that may impact labelling compliance, linguistic review, artwork approval, or implementation timelines.
Participate in project meetings with internal and external partners to align on priorities, clarify requirements, resolve operational challenges, and drive completion of milestones.
Support effective collaboration across time zones by maintaining clear communication, structured follow-up, and accurate tracking of open actions.
6. Process Improvement, Inspection Readiness, and Knowledge Sharing
Contribute to continuous improvement initiatives focused on labelling processes, EU labelling workflows, linguistic review coordination, artwork review, templates, trackers, and system usage.
Support inspection readiness by ensuring labelling documentation, approval records, SOP adherence, and implementation evidence are complete, accurate, and readily available.
Collect and analyse labelling operations data to identify trends, process gaps, cycle-time delays, and opportunities to improve efficiency, compliance, and transparency.
Assist in developing or refining training materials, job aids, process maps, and work instructions to promote consistent execution of labelling procedures.
Provide guidance and operational support to peers and junior team members on labelling compliance processes, EU labelling requirements, artwork review, linguistic review, and quality expectations.
Stay informed of emerging EU labelling expectations, regulatory requirements, and industry practices that may impact Product Information, artwork processes, or labelling implementation activities.
Basic Qualifications
Bachelor’s degree or Master’s degree with 9 to 12 years of directly related experience in Regulatory Affairs, labelling compliance, artwork management, quality, or a related pharmaceutical or biotechnology function.
Equivalent combinations of education and relevant experience may also be considered.
Preferred Qualifications
Experience supporting EU and/or global labelling processes, including Product Information updates, linguistic review, mock-up review, artwork review, approval workflows, and implementation activities.
Familiarity with EU labelling requirements, approved Product Information, country-specific implementation needs, and coordination with regional affiliates or local regulatory contacts.
Experience working with labelling management systems, artwork management systems, or document management platforms such as Veeva Vault or similar tools.
Understanding of end-to-end labelling implementation, from approved regulatory text through translation, linguistic review, artwork creation, review, approval, release, and market implementation.
Experience coordinating Summary of Product Characteristics, Package Leaflet, outer labelling, inner labelling, mock-ups, and printed packaging components.
Demonstrated ability to manage multiple labelling deliverables in a matrix organisation while meeting deadlines and maintaining compliance.
Strong collaboration and communication skills, with experience working across international teams, external vendors, and multiple time zones.
Experience coordinating with translation vendors, artwork vendors, Regulatory Affairs, Quality, Operations, Supply Chain, and regional or local stakeholders.
Strong analytical and problem-solving skills, with excellent attention to detail and the ability to identify risks, gaps, inconsistencies, or discrepancies in labelling documentation.
Ability to support process improvement initiatives and contribute to efficient, compliant, and scalable labelling workflows.
Familiarity with inspection readiness expectations, SOP compliance, documentation standards, quality-controlled processes, and audit-ready record maintenance.
.Amgen develops and makes biologic medicines, which are drugs built from proteins and antibodies grown in living cells, for serious conditions such as heart disease, cancer, and bone loss. Its anemia drug Epogen, approved in 1989, became one of the biotechnology industry's first blockbuster medicines. Amgen grows these drugs in large tanks called bioreactors, and its products include the cholesterol drug Repatha, the bone-building drug Evenity, and the severe asthma drug Tezspire. It earns money by selling these medicines, mostly through large drug wholesalers that supply hospitals and pharmacies. Amgen was founded in 1980 and is based in Thousand Oaks, California.
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