Amgen - Regulatory Labeling Manager

Overview:

The 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:

- 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.

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

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

- Partner with global, regional, and local stakeholders across Regulatory Affairs, Quality, Operations, Supply Chain, and affiliates to support compliant and timely labelling implementation.

- Contribute to continuous improvement initiatives focused on labelling processes, EU labelling workflows, linguistic review coordination, artwork review, templates, trackers, and system usage.

Basic Qualifications:

- Bachelor's degree 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.

Location:

- Hyderabad, Telangana

Job Type:

- Full time

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