Regulatory Labeling Mgr at Amgen
Role Type: Full-Time Recruitment
Year: 2026
🛠️ Key Skills Required
Please refer to the Job Description section below for the full list of required skills and qualifications.
📌 Hiring Details
Amgen is hiring talented professionals for the position of Regulatory Labeling Mgr in India - Hyderabad. This opportunity is ideal for candidates looking to build a strong career in the IT industry in 2026. Applicants should carefully review the eligibility criteria, required skills, and selection process before applying online.
The recruitment drive for 2026 offers a great chance for job seekers to join a reputed organization. Make sure to prepare well for the interview and submit your application before the deadline. Read below for full details on how to apply, educational qualifications, and other important instructions.
💡 Candidate Insights
Amgen has announced exciting career opportunities for the position of Regulatory Labeling Mgr in India - Hyderabad. This is a great chance for qualified candidates to join a globally recognized organization in 2026. Read on for complete details on eligibility, responsibilities, and how to apply.
✅ Why Apply at Amgen?
- Work with a globally recognized Fortune-500 organization.
- Competitive salary packages and excellent employee benefits.
- Structured career growth and learning opportunities.
- Exposure to cutting-edge technologies and global projects.
📋 Job Requirements & Description
Career Category
RegulatoryJob 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
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.
.🚀 Why Regulatory Labeling Mgr is a Strategic Career Move in 2026
Joining Amgen as a Regulatory Labeling Mgr offers excellent growth prospects. Here's why this role is trending:
- The IT sector in India is projected to grow significantly in 2026.
- Continuous learning and upskilling are key to a long-term career.
Industry Insight: General roles in India - Hyderabad are currently seeing high demand.
🎯 How to Prepare for Regulatory Labeling Mgr Role
To crack the interview at Amgen, focus on the following:
- Mock interviews can significantly boost your confidence.
- Prepare answers for common behavioral questions (STAR method).
- Research the company's culture and values before the interview.
🔗 Important Links & Apply
💡 Quick Interview Tips
- 📌 Research Amgen's recent projects and company values before the interview.
- 📌 Prepare examples using the STAR method for behavioural questions.
- 📌 Review fundamentals related to the Regulatory Labeling Mgr role — especially domain-specific tools.
🎯 Final Thoughts
This Regulatory Labeling Mgr role at Amgen is a fantastic opportunity to grow your career with a leading organization. Make sure your resume is updated and highlights your relevant skills before applying. We wish you the very best for your application process. Don't wait—apply today!
Kishan Prajapati
Career Researcher & IT Industry Analyst. Helping freshers and professionals find verified private IT job opportunities in India.