Sr. Associate Labelling

As a Senior Associate in Labeling Compliance, you will play a crucial role in planning, coordinating, and executing global labeling compliance initiatives within the Regulatory Affairs department. Your responsibilities will include: - **Labeling Strategy and Execution** - Coordinate day-to-day labeling activities to ensure compliance with global regulatory requirements. - Act as a key contact for cross-functional teams, offering guidance on labeling procedures, formats, and timelines. - Execute labeling change requests, monitor progress, and maintain accurate documentation in labeling management systems. - **Cross-functional Collaboration in a Matrix Organization** - Collaborate with global and regional stakeholders to streamline labeling processes and ensure alignment across multiple time zones. - Identify and escalate potential compliance risks or delays, partnering with relevant teams to resolve issues efficiently. - Engage with global affiliates to gather requirements, clarify expectations, and facilitate smooth implementation of labeling changes. - **Process Improvement and Compliance** - Contribute to continuous improvement initiatives by optimizing labeling processes, templates, and workflows. - Support the maintenance of inspection readiness by ensuring adherence to quality standards and internal policies. - Analyze data on labeling operations, recommending improvements to enhance transparency, speed, and accuracy. - **Stakeholder and Vendor Coordination** - Collaborate with vendors involved in labeling activities to ensure quality and timeline requirements are met. - Monitor vendor performance against established SLAs and address any gaps or issues promptly. - Participate in meetings with internal and external partners to align on project deliverables and drive timely completion of milestones. - **Training and Knowledge Sharing** - Provide guidance and operational support to junior staff and peers on labeling compliance processes and best practices. - Assist in developing or refining training materials and job aids to promote consistent understanding and application of labeling procedures. - Stay updated on emerging regulatory requirements and industry trends, sharing insights that could impact labeling strategies and practices. **Qualifications Required:** - Doctorate degree OR - Masters degree with 2 to 4 years of related experience OR - Bachelors degree with 4 to 6 years of related experience OR - Diploma with 8 to 10 years of related experience **Preferred Qualifications:** - Experience with labeling management systems like 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 effectively. - Strong collaboration and communication skills to work with international teams. - Proven problem-solving capabilities and attention to detail. - Experience in vendor coordination to ensure quality and compliance.,