Amgen Recruitment 2026: Regulatory Labeling Manager (Hyderabad)

Amgen, a global biotechnology pioneer dedicated to developing innovative human therapeutics, is inviting online applications for the position of Regulatory Labeling Manager at its capability center in Hyderabad.

This role sits within the Global Regulatory Affairs organization and oversees end-to-end labeling lifecycle operations, including Product Information (PI) updates, linguistic reviews, packaging artwork approvals, and post-approval compliance across EU and global markets.

Position Summary

Parameter	Details
Organization	Amgen
Designation	Regulatory Labeling Manager
Job Location	Hyderabad, Telangana
Functional Area	Regulatory Affairs / Global Labeling
Industry Segment	Biotechnology / Pharmaceuticals
Employment Type	Full-Time (Matrixed Environment)
Application Deadline	20 October 2026

Eligibility & Qualifications

Education: Bachelor’s degree or Master’s degree in Pharmacy, Life Sciences, Biotechnology, or a related scientific discipline.
Experience:
- 5+ years of total pharma experience, with a core profile of 9 to 12 years of directly relevant experience in Regulatory Affairs, labeling compliance, artwork coordination, or quality systems.
- Equivalent combinations of advanced education and proven industry experience will also be considered.
Core Competencies:
- In-depth understanding of EU regulatory pathways (Centralised, Decentralised, MRP, and National procedures).
- Hands-on proficiency with Labeling and Document Management Systems (e.g., Veeva Vault or equivalent platforms).
- Familiarity with Summary of Product Characteristics (SmPC), Package Leaflets (PIL), inner/outer carton mock-ups, and printed packaging components.
- Cross-functional collaboration skills across multiple time zones, regional affiliates, translation partners, and artwork vendors.

Key Responsibilities

Labeling Compliance & Change Control:
- Manage and execute operational change requests, document tracking, and lifecycle updates across EU and global markets.
- Ensure packaging updates strictly align with approved Marketing Authorizations (MA) and internal quality guidelines.
EU Product Information Management:
- Coordinate revisions for SmPC, PIL, blister foils, cartons, and inner/outer labeling components.
- Interface with regional regulatory teams to gather market-specific implementation timelines and technical requirements.
Linguistic Review & Translation Coordination:
- Facilitate country-specific translation workflows alongside local affiliates and external translation agencies.
- Address terminology nuances, Member State health authority feedback, and local agency comments.
Artwork Review & Implementation:
- Oversee artwork workflows ensuring printed materials (leaflets, labels, cartons, blisters) accurately reflect approved labeling copy.
- Maintain rigorous version control and clear audit trails for inspection readiness.
Inspection Readiness & Process Optimization:
- Ensure documentation packages, approval records, and SOP adherence records are maintained in an audit-ready state.
- Analyze cycle times and workflow metrics to identify continuous improvement opportunities.

How to Apply

Eligible candidates can apply directly through the official Amgen Careers Portal under the Hyderabad job listings before the cutoff date on 20 October 2026.