2 Labeling Strategy Jobs

As a Regulatory Affairs Labeling Specialist, you will be responsible for creating a labeling strategy for health authority interactions and handling labeling queries from Health Authorities (HA) or Country Organizations (CO) for the assigned program/products. Your key duties will include ensuring artwork management for initial submissions/commercial launch activities in coordination with the Cross-Functional Team (CFT). Additionally, you will participate in the review of promotional materials and represent Regulatory in CFT meetings to make strategic decisions ensuring no misleading information is provided. You will also be responsible for coordinating with external vendors to prepare/review translated documents to support Global Regulatory Submissions. Your role will involve preparing Structured Product Labeling (SPL) for initial submissions/labelling responses and drug listings for approved products according to business/agency timelines. You will also oversee the change management process of Company Core Data Sheets (CCDS), Non-CCDS, and annual reportable labeling changes. Furthermore, you will analyze competitor information such as labels and approval packages for regulatory policy projects and/or labeling projects. It will be your duty to escalate, notify, and resolve any issues that may impact the final labeling submission. You will be accountable for maintaining an internal tracker for CCDS, Non-CCDS, and annual reportable labeling changes and submissions. Additionally, you will manage Global Labelling Impact Assessment, including Reference Listed Drug (RLD) updates and Safety Information Updates. A key part of your role will involve leading and directing the Labelling Team members to adhere to business processes and ensure high-quality work from the first instance. To be successful in this role, you should possess a degree in B. Pharmacy/M. Pharmacy/B.Sc./M.Sc. along with a minimum of 5 to 10 years of experience in the Global Labelling domain.,

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.