Job Title: Senior Associate, Labeling Compliance

Overview

In this pivotal role, you will support the planning, coordination, and execution of global labeling compliance initiatives within the Regulatory Affairs department. Working in a fast-paced, matrixed environment with no direct reports, you will collaborate extensively with cross-functional and regional teams—including Regulatory Affairs, Quality, Operations, and Supply Chain—to ensure that labeling meets all global regulatory requirements and maintains the highest standards of quality. This position offers a unique opportunity to lead initiatives, contribute to strategic projects, and drive continuous improvement, all while building strong partnerships across the organization.

Key Responsibilities

1. Labeling Strategy and Execution

• Coordinate day-to-day labeling activities, ensuring timely updates and compliance with global regulatory requirements.

• Serve as a key contact for cross-functional teams, providing operational support and guidance on labeling procedures, formats, and timelines.

• Execute labeling change requests, track progress, and maintain accurate documentation in labeling management systems.

2. Cross-functional Collaboration in a Matrix Organization

• Collaborate with global and regional stakeholders (Regulatory Affairs, Quality, Operations, Supply Chain) to streamline labeling processes and ensure alignment across multiple time zones.

• Identify and escalate potential compliance risks or delays in labeling updates, partnering with relevant teams to resolve issues efficiently.

• Proactively engage with global affiliates to gather requirements, clarify expectations, and facilitate smooth implementation of labeling changes.

3. Process Improvement and Compliance

• Contribute to continuous improvement initiatives, optimizing labeling processes, templates, and workflows to enhance efficiency and compliance.

• Support the maintenance of inspection readiness by ensuring that documentation, SOPs, and labeling processes adhere to quality standards and internal policies.

• Collect and analyze data on labeling operations, recommending improvements to enhance transparency, speed, and accuracy.

4. Stakeholder and Vendor Coordination

• Collaborate with vendors involved in labeling activities (e.g., translation services, artwork vendors) to ensure they meet quality and timeline requirements.

• Assist in monitoring vendor performance against established SLAs, promptly highlighting any gaps or issues to internal partners.

• Participate in regular meetings with internal and external partners to align on project deliverables, address operational challenges, and drive timely completion of milestones.

5. Training and Knowledge Sharing

• Provide guidance and operational support to junior staff and peers on labeling compliance processes, best practices, and quality standards.

• Help develop or refine training materials and job aids, promoting consistent understanding and application of labeling procedures across teams.

• Stay updated on emerging regulatory requirements and industry trends, sharing insights that could impact labeling strategies and practices.

Basic Qualifications:

• Doctorate degree OR

• Master’s degree and 2 to 4 years of directly related experience OR

• Bachelor’s degree and 4 to 6 years of directly related experience OR

• Diploma and 8 to 10 years of directly related experience

Equivalent combinations of education and experience may be considered.

Preferred Qualifications

• Experience working with labeling management systems (e.g., Veeva Vault) or other document management platforms.

• Familiarity with global labeling regulations and end-to-end labeling processes.

• Demonstrated ability to plan and manage projects in a matrix organization, meeting deadlines and handling multiple tasks effectively.

• Strong collaboration and communication skills, comfortable working with international teams across time zones.

• Proven problem-solving capabilities, with an analytical mindset and attention to detail.

• Experience in vendor coordination, ensuring quality and compliance with established metrics.