Sr. Manager

3 days ago

Hyderabad, Telangana, India Amgen Inc Full time
Job Description

Key Responsibilities

1. Leadership & Team Management

Manage and developa team of labeling specialists, providing direction, mentorship, and performance feedback to encourage professional growth.

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

Set clear goals and prioritiesfor 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 planswith timelines, milestones, and resources, proactively identifying and mitigating potential risks or delays.

3. Compliance & Inspection Readiness

Ensure alignmentwith global regulatory requirements and company standards, maintaining consistent inspection readiness.

Implement effective controlsfor tracking, auditing, and updating labeling content, ensuring accurate and compliant product information.

Collaborate with quality assuranceteams to address and close any compliance gaps or findings from audits.

4. Stakeholder Management

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

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

5. Continuous Improvement & Systems Optimization

Identify opportunitiesto 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 practicesby 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

Experiencewith electronic Labeling Management Systems (e.g., Veeva Vault).

Proficiencyin project management and vendor oversight, ideally within a global or matrixed organization.

Solid understandingof global regulatory labeling requirements, including US, EU, and emerging markets.

Strong analytical skillsfor troubleshooting, process mapping, and continuous improvement initiatives

Excellent communicationand interpersonal skills, with the ability to influence and build relationships across diverse teams.

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