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Regulatory Labeling Manager

By Admin · Regulatory Affairs

HYDERABAD (IN)ONSITEPOSTED: 9/12/2026
HEALTHCAREFull-time
HIRING ORGANIZATIONAMGENBiotechnology / Pharmaceuticals
Amgen

ROLE OVERVIEW

Manage the planning, coordination, and execution of US regional regulatory labeling activities across the pharmaceutical product lifecycle.

ROLE DEFINITION & RESPONSIBILITIES

  • •Lead and coordinate US labeling process management activities across assigned products, ensuring deliverables are planned, reviewed, and approved.
  • •Serve as the primary operational point of contact working cross-functionally with Regulatory, Artwork, Supply Chain, and Publishing.
  • •Manage US labeling activities supporting initial and supplemental submissions and Health Authority negotiations.
  • •Coordinate the creation, review, approval, and lifecycle management of US labeling artwork projects.
  • •Coordinate Structured Product Labeling (SPL) activities including initiation, review, and QC of packages.
  • •Ensure labeling activities are executed in compliance with applicable Amgen procedures and regulatory requirements.
Reporting Hierarchy: Reports to Director of Global Labeling Compliance • Team size: 8-12

QUALIFICATIONS & REQUIREMENTS

REQUIRED QUALIFICATIONS

  • Bachelor’s or Master’s degree with 9 to 12 years of directly related experience in Regulatory Affairs, regulatory labeling, or related pharmaceutical function.
  • Strong knowledge of US FDA pharmaceutical or biologic labeling and associated regulatory processes.
  • Experience supporting Health Authority submissions, questions/negotiations, and post-approval implementation.
  • Familiarity with structured product labeling (SPL) and labeling artwork development.

PREFERRED QUALIFICATIONS

  • •Experience with RIM or comparable regulatory information management systems
  • •Experience managing multiple products and competing priorities simultaneously
  • •Understanding of labeling quality, compliance, change management, and Right First Time principles

REQUIRED VERIFIED SKILLS

Regulatory Affairs
Regulatory Labeling
Labeling Operations
Artwork Management
Compliance

COMPENSATION & REWARDS

Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Comprehensive medical insurance, retirement plans, performance bonuses, flexible work policies
Competitive compensation benchmarked against top-tier global biopharmaceutical companies in India.

ORGANIZATION CONTEXT & CULTURE

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing, and delivering innovative human therapeutics.

TEAM SIZE: 25,000+ employees
INDUSTRY: Biotechnology / Pharmaceuticals
Culture: Amgen fosters a science-based, patient-focused culture that values diversity, collaboration, and continuous improvement.

EXPECTED CAREER ROADMAP

Clear career progression pathways into Senior Director or Global Head roles within Regulatory Affairs and Labeling Operations.

APPLICATION ADVISORY

Highlight your specific expertise in FDA labeling, SPL processes, and cross-functional project management during the interview.
RECOMMENDED TRAINING
1/5
The Fundamentals of Regulatory Affairs

The Fundamentals of Regulatory Affairs

READY TO SUBMIT?

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