Manager – Labeling
Location: Hyderabad, India
Job ID: R-218597
Posted On: June 30, 2025
Employment Type: Full-Time | On-Site
About Amgen:
Amgen is a global pioneer in biotechnology with a mission to serve patients suffering from serious illnesses. Since 1980, Amgen has focused on delivering innovative therapies across four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—while improving patient outcomes and quality of life. The company fosters a collaborative, science-driven culture built on integrity, excellence, and a shared commitment to improving lives.
Position Overview:
As Manager – Labeling, you will oversee the full spectrum of global labeling activities, ensuring regulatory compliance across regions. You will lead the planning, coordination, and execution of labeling projects and updates while enhancing process efficiency and maintaining high quality standards. This role requires cross-functional collaboration, strong attention to detail, and a proactive approach to risk management and process optimization.
Key Responsibilities:
Global Labeling Management:
Oversee and execute labeling changes (updates, reviews, approvals) aligned with global regulatory guidelines.
Maintain and improve labeling templates, SOPs, and documentation to ensure uniformity and compliance.
Cross-Functional Collaboration:
Coordinate with Regulatory Affairs, Quality, Clinical, Operations, and Supply Chain teams to address labeling needs and resolve issues.
Serve as a subject matter expert on global labeling practices.
Planning & Execution:
Develop and track project plans with defined timelines, milestones, and deliverables.
Monitor risk, implement mitigation plans, and ensure timely project delivery.
Process Improvement & Compliance:
Identify and implement improvements to labeling workflows and document management.
Ensure inspection-readiness with thorough documentation, quality controls, and updated records.
Operational & Technical Oversight:
Review labeling content, translations, and artwork for accuracy and compliance.
Address and resolve technical issues with labeling tools and systems (e.g., Veeva Vault).
Mentorship & Development:
Guide and train junior team members in labeling standards and system tools.
Promote best practices and continuous knowledge-sharing within the team.
Qualifications:
Basic Qualifications:
Master’s degree with 6–8 years of relevant experience
OR
Bachelor’s degree with 8–10 years of relevant experience
OR
Diploma with 10–12 years of relevant experience
Required Skills & Experience:
Expertise in end-to-end labeling processes and global pharmaceutical/biologic labeling regulations.
Proficient in Labeling Management Systems like Veeva Vault and documentation tools.
Strong planning, organizational, and problem-solving capabilities.
Excellent communication and collaboration skills.
Experience implementing process improvements and maintaining audit readiness.
Soft Skills:
High attention to detail with excellent verbal and written communication.
Strong leadership, influencing, and negotiation skills in team environments.
Effective time management and ability to work independently.
Resilience and commitment to achieving results in a regulated environment.
Estimated Salary: ₹45–60 LPA (based on industry benchmarks and experience level)
Gujarat :
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