Regulatory Labeling Mgr

Amgen; Hyderabad; On-site; INR 2,800,000 - 3,600,000; Full time

Job summary

Amgen in Hyderabad is seeking a Regulatory Labeling Manager to guide EU and global labelling compliance, coordinate Product Information updates, linguistic reviews, artwork coordination, and implementation of approved labelling changes across markets. The role requires coordinating with global teams to ensure accuracy and timely delivery.

The position offers matrixed collaboration with regulatory, quality, and supply chain teams, focusing on inspection readiness, translation management, and

Qualifications

• Bachelor's or Master's degree with 9–12 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.

Responsibilities

• Coordinate day-to-day EU/global labelling changes to support timely, compliant implementation across markets.
• Track labelling deliverables, timelines, and maintain records in applicable systems.
• Serve as operational contact for labelling processes, guiding internal stakeholders on requirements, formats, and timelines.
• Ensure labelling updates align with approved Product Information, procedures, and quality standards.
• Identify compliance risks, delays, or gaps and escalate to stakeholders for resolution.
• Support EU labelling activities across centralised, decentralised, mutual recognition, and national procedures.
• Coordinate updates to Product Information components (SOPs, leaflets, packaging text).
• Collaborate with regional/local Regulatory contacts and vendors to implement changes.
• Monitor milestones, review comments, approvals, and implementation status for timely delivery.
• Facilitate linguistic review activities with affiliates, translation vendors, and internal reviewers.
• Coordinate country-specific translations to maintain consistency with source information.
• Resolve translation queries and terminology discrepancies with stakeholders.
• Maintain records of linguistic decisions, approvals, and final texts in systems.
• Coordinate artwork review, approval, and implementation ensuring labeling reflects approved text.
• Review artwork components (cartons, labels, leaflets, blisters) for accuracy and compliance.
• Collaborate with artwork vendors, Quality, Supply Chain, and affiliates to enable timely artwork release.
• Monitor artwork timelines and address delays or bottlenecks with stakeholders.
• Maintain records of artwork decisions, comments, and approvals in systems.
• Partner with global/regional/local teams and external vendors to support compliant labelling implementation.
• Engage vendors to meet quality, timelines, and service levels.
• Participate in project meetings to align priorities and resolve challenges.
• Promote cross-time-zone collaboration with clear communication and follow-up.
• Contribute to process improvements, inspection readiness, and knowledge sharing.

Skills

Regulatory Affairs

Labelling Compliance

Stakeholder Management

Cross-functional Coordination

Attention to Detail

Education

Bachelor's/Master's degree in related field

Tools

Veeva Vault

Artwork Management System

Document Management System

Job description

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: 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 escalates issues to the appropriate stakeholders for timely resolution.
• 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.
• 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.
• 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.
• 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.
• 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.