Sr. Manager

Amgen Inc.

3.6

(9)

Hyderabad, India

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-206578

    Position summary

    to encourage professional growth.

    • Foster a collaborative environment by guiding cross-functional teams to meet global labeling objectives and deliverables.

    • Set clear goals and priorities for the labeling team, ensuring alignment with broader Regulatory Affairs and organizational strategies.

    2. Labeling Planning & Execution

    • Oversee end-to-end labeling projects, from content creation and revisions to final implementation, ensuring on-time, in-full delivery.

    • Coordinate across functions (e.g., Regulatory Affairs, Quality, Operations, Supply Chain) and regions to manage complex labeling changes and meet international requirements.

    • Develop robust project plans with timelines, milestones, and resources, proactively identifying and mitigating potential risks or delays.

    3. Compliance & Inspection Readiness

    • Ensure alignment with global regulatory requirements and company standards, maintaining consistent inspection readiness.

    • Implement effective controls for tracking, auditing, and updating labeling content, ensuring accurate and compliant product information.

    • Collaborate with quality assurance teams to address and close any compliance gaps or findings from audits.

    4. Stakeholder Management

    • Manage relationships with translation and artwork vendors, defining clear Service Level Agreements (SLAs) and key performance indicators.

    • Communicate effectively with global teams, regional affiliates, and third-party partners to maintain transparency and drive successful outcomes.

    5. Continuous Improvement & Systems Optimization

    • Identify opportunities to enhance labeling workflows and processes, driving efficiencies and cost savings without compromising quality.

    • Leverage technology (e.g., Labeling Management Systems) to improve labeling accuracy, data integrity, and cross-functional visibility.

    • Champion best practices by developing SOPs, work instructions, and training materials to embed quality and compliance in all labeling activities.

    Basic Qualifications:

    • Doctorate degree and 3 years of Pharmaceutical, Regulatory, or Quality Management experience OR

    • Master's degree and 8 to 12 years of Pharmaceutical, Regulatory, or Quality Management experience OR

    • Bachelor's degree and 12 to 14 years of Pharmaceutical, Regulatory, or Quality Management experience OR

    • Diploma and 16 to 18 years of Pharmaceutical, Regulatory, or Quality Management experience

    Preferred Qualifications

    • Experience with electronic Labeling Management Systems (e.g., Veeva Vault).

    • 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.

    .

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging