Sr. Manager - Global Labeling Compliance Job at Amgen (Hyderabad)

Job Description

In this crucial role, you will oversee the planning and execution of global labeling compliance initiatives for our portfolio, working cross-functionally to ensure all labeling activities meet regulatory, quality, and operational standards. As a Senior Manager, you will lead a dedicated team of labeling professionals, drive continuous improvement, and serve as a key liaison between regional and global stakeholders. Your leadership will ensure timely and accurate labeling deliverables across multiple markets, positioning our organization at the forefront of compliance and innovation in the biotech industry.

Job Responsibility

Oversee the planning and execution of global labeling compliance initiatives for our portfolio, working cross-functionally to ensure all labeling activities meet regulatory, quality, and operational standards
Lead a dedicated team of labeling professionals, drive continuous improvement, and serve as a key liaison between regional and global stakeholders
Manage and develop a team of labeling specialists, providing direction, mentorship, and performance feedback
Foster a collaborative environment by guiding cross-functional teams to meet global labeling objectives
Set clear goals and priorities for the labeling team
Oversee end-to-end labeling projects, from content creation and revisions to final implementation
Coordinate across functions and regions to manage complex labeling changes
Develop robust project plans with timelines, milestones, and resources
Ensure alignment with global regulatory requirements and company standards
Implement effective controls for tracking, auditing, and updating labeling content
Collaborate with quality assurance teams to address and close compliance gaps
Oversee and manage relationships with labeling vendors
Communicate effectively with global teams, regional affiliates, and third-party partners
Identify opportunities to enhance labeling workflows and processes
Leverage technology (e.g., Labeling Management Systems) to improve labeling accuracy
Champion best practices by developing SOPs, work instructions, and training materials

Requirements

Master’s degree and 10 to 12 years of Pharmaceutical, Regulatory, or Quality Management experience
Bachelor’s degree and 12 to 14 years of Pharmaceutical, Regulatory, or Quality Management experience

Nice to have

Experience with electronic Labeling Management Systems (e.g., Veeva Vault) and Artwork management
Proficiency in project management and vendor oversight, ideally within a global or matrixed organization
Solid understanding of global regulatory labeling requirements, including US, EU, and emerging markets
Strong analytical skills for troubleshooting, process mapping, and continuous improvement initiatives
Excellent communication and interpersonal skills, with the ability to influence and build relationships across diverse teams

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Sr. Manager - Global Labeling Compliance

Job Description

Job Responsibility

Requirements

Nice to have

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