PHARMAFull-time
Regulatory Labeling Mgr
By Admin · Regulatory Affairs
HYDERABAD (IN)ONSITEPOSTED: 9/21/2026
PHARMAFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
ROLE OVERVIEW
Support the planning, coordination, and execution of EU and global labelling compliance activities within the Regulatory Affairs organisation.
ROLE DEFINITION & RESPONSIBILITIES
- •Labelling Compliance and Change Management
- •EU Labelling Process and Product Information Coordination
- •Linguistic Review Coordination
- •Artwork Review, Approval, and Implementation
- •Cross-functional and Vendor Coordination
- •Process Improvement, Inspection Readiness, and Knowledge Sharing
Reporting Hierarchy: Reports to Director, Regulatory Affairs • Team size: 4-10
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED 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
PREFERRED QUALIFICATIONS
- •Experience supporting EU and/or global labelling processes including Product Information updates and linguistic review
- •Familiarity with EU labelling requirements
- •Experience with Veeva Vault or similar document management platforms
- •Understanding of end-to-end labelling implementation
- •Strong collaboration and communication skills
REQUIRED VERIFIED SKILLS
Regulatory Labeling
EU Labelling
Linguistic Review
Artwork Management
Regulatory Affairs
Compliance
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Health insurance, PF, Paid leave, Global wellness benefits
Competitive executive compensation benchmarked against top-tier biotechnology and pharmaceutical capability centers in India.
ORGANIZATION CONTEXT & CULTURE
Amgen is a leading global biotechnology company dedicated to discovering, developing, and delivering innovative human therapeutics for serious illnesses.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biotechnology / Pharmaceuticals
Culture: Committed to unlocking the potential of biology for patients suffering from serious illnesses through science and innovation.
EXPECTED CAREER ROADMAP
Clear progression pathways into Senior Manager Regulatory Labeling, Associate Director Regulatory Affairs, or Global Head of Labeling.
APPLICATION ADVISORY
Highlight your hands-on experience with EU regulatory labelling, linguistic review coordination, and artwork management systems in your application.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.