Sr. Manager Labeling

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.

Key Responsibilities

1. Leadership & Team Management

• Manage and develop a team of labeling specialists, providing direction, mentorship, and performance feedback 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.