Job descriptionJob Description / Role Profile Function: Global Labeling Operations Department: Global Regulatory Affairs OBJECTIVES/PURPOSE: Responsible for leading Regional Labeling activities in supporting Local Operating Company (LOC) Regulatory Leads towards achievement of seamless execution of labeling processes and continuous process improvement. Partners with LOC Regulatory Leads to enhance labeling operational excellence and compliance at the LOC level. Drives standardization of implementation of Global Labeling processes and use of Global Labeling systems (MEDIVA RIM for Labeling) at the LOC level by providing proactive training, sharing best practices and guidance to LOC Regulatory Leads to achieve operational excellence and ensure compliance. Acts as a conduit between Global Labeling and LOC Regulatory Affairs, establishing a two-way communication channel to strengthen understanding of global processes, share challenges and provide support during audits/inspections. Supports LOC Regulatory Leads in the management of single country products by defining process and ways of working for the maintenance of the local product labeling in partnership with Global Labeling function. ACCOUNTABILITIES: • Management of local product labeling lifecycle Provides guidance to LOC Regulatory Leads on the management of local labeling exceptions. Proactively supports LOC Regulatory Leads to ensure correct market label dependencies are accurately reflected in Labeling systems. Oversight of local labeling safety variations submissions; ensures that any deferral requests are submitted/approved on time and with adequate justification and overall on time submission of local labeling safety variations. Supports LOC Regulatory Leads with labeling related Quality Events (Deviations), providing guidance on good investigation practices, sharing best practices across LOCs and ensures a standardized approach to CAPAs and Effectiveness Checks as required. • Global Labeling Systems support to LOC Provides global labeling systems support, ensuring compliance with regulatory requirements and maintaining accurate and up-to-date labeling information across all regions. Ensures global/local labeling tracking events are appropriately created, managed through their lifecycle and closed out by LOC Regulatory Leads. Works with Labeling Process Excellence to create and maintain simplified slides, instruction manuals, and FAQ sheets as appropriate to assist with relevant labeling and system processes. • Support LOC Audits/Inspections Partners with LOC Regulatory Leads to proactively ensure audit/inspection readiness. Provide support to Local Labeling SMEs on presentations related to global/local labeling processes for inspections and audits. Supports the LOC together with Global Labeling Compliance for the development of responses and CAPAs related to local labeling for audits/inspections. • Working with the Local Operating Company and GRA, including (but not limited to) GRA Regional, Global Labeling and GRA Compliance Liaises with US Labeling Operations, EU Labeling Operations, Labeling Devices Lead and Labeling Compliance to ensure labeling objectives and timelines are met. Represents global labeling in departmental and cross-functional taskforces and initiatives. Develops effective working relationships with Local Regulatory Lead, Global Labeling Lead, Regional and Global Regulatory Team, Global Labeling Compliance, GRA Compliance, Cross-functional Teams and other LOC stakeholders as required. • Escalation Process and Stakeholder Management Appropriately escalates issues to Global Labeling management and proposes risk mitigation strategies. Strategically develop and cultivate strong relationships among functions represented at the Labeling cross functional teams both at global and LOC level including regulatory, clinical, safety, medical affairs, quality and commercial, to ensure the highest level of communication effectiveness for labeling and content. • Labeling Process Training Partners with Global Regulatory Affairs Compliance to ensure that appropriate labeling training curricula for Global and Local Labeling are assigned to LOC Regulatory Leads and are kept up to date. Collaborates with Global Labeling Process Excellence & Compliance to develop, maintain and execute training for global/local labeling processes. Conducts live training sessions on labeling systems and processes, including coordination of scheduling and attendance based on region. • Continuous Improvement Actively contributes to the continuous improvement of labeling processes, identifying opportunities for optimization and implementing effective strategies to enhance agility, efficiencyand accuracy. Obtains feedback from the LOC labeling user community on areas where the processes require further guidance and assists in executing those changes. Supports process revisions, continuous improvements of Global and Local Labeling processes and business requirements. • Leadership Behaviors Fosters a culture of process excellence to enable labeling strategy execution and enhance compliance and patient outcomes. Constructively challenges the way we have always done things and provides alternatives. Enables information sharing, helps groups to understand each other and brings them together. Actively develops relationships inside and outside their function and geography. Delivers on commitments, following through to resolution by addressing situations head-on and taking action. Demonstrates willingness to quickly change approach when circumstances warrant. Views failures as learning opportunities and adjusts approach based on lessons learned. Education & Competencies (Technical and Behavioral): • BSc degree preferred; BA accepted. • Advanced scientific degree (MSc, PhD, or PharmD) preferred. • 8+ years of pharmaceutical industry experience is preferred. This is inclusive of 6 years of labeling experience or a combination of 5+ years' regulatory and/or related experience i.e. compliance, training. • Strategic Thinking Ability to develop & execute clear and practical solutions to enable Local Operating Companies to be compliant with the local labeling requirements. Ability to develop & execute clear and practical solutions to enable Local Operating Companies to manage single country product labels (no CCDS) and labels of products approved in non-major markets (following a partial divestment and/or withdrawal strategy or products that are considered generics). Demonstrates an understanding of the core business aspect. • Communication Ability to effectively collaborate with global cross-functional teams. Ability to use communication skills to transfer knowledge, convey complex regulatory information in a clear and concise manner in written, verbal and group presentation formats. Ability to promote regulatory decisions across global cross-functional teams. Ability to actively listen to stakeholders, understanding their perspectives and addressing their concerns. • Analytical and Problem-Solving Skills Demonstrates strong analytical and problem-solving skills with ability to analyze risk and think strategically. Ability to comprehend and explain complex technical regulatory issues. Ability to proactively identify risks, develop risk mitigation strategies, and appropriately escalate to leadership. • Technical Knowledge of US, EU, Japan and Global product labeling requirements, regulations, and guidelines. Knowledge of US and/or EU regulatory requirements and guidelines. Knowledge of other relevant regional regulatory nuances and requirements. Knowledge of scientific principles and regulatory/quality systems relevant to drug development. Understanding of the broad concepts within global labeling and implications across the organization and globally. Knowledge of Health Authority audit process and ability to participate in partner / health authority audits and inspections. • Business/Organizational Awareness Strong knowledge of labeling role in project teams, and importance of cross-functional collaboration. Knowledge of R&D organizational structure, including its functions and interdependencies. Demonstrates project management skills and ability to independently deliver accurate and complete work while adhering to designated timelines for the execution of submission plans, regulatory requirements and business objectives. Demonstrates a strategic mindset and ability to align product labeling strategies with broader business objectives. Ability to independently prioritize assigned global labeling activities and tasks. • Leadership Acts proactively and effectively as member of multi-disciplinary teams. Ability to effectively lead multi-disciplinary, cross-functional teams with appropriate supervision and guidance. Ability to provide alternatives and to adopt breakthrough ideas, innovations and initiatives. Acts as an ally to support individuals as a whole and intentionally promote an inclusive culture and fosters a climate that encourages open dialogue, feedback and diverse opinions. • Core competencies Ethical decision making : considers the impact of decisions and actions on others, adhering to professional codes of conduct and making choices that align with the client's values. Timeline management: ability to effectively manage time, prioritize tasks, and meet deadlines. Proactiveness, adaptability and flexibility: ability to adapt to changing circumstances, learn new skills and work with diverse global team by being open to feedback. Attention to details : demonstrates attention to details ensuring accuracy of the labeling deliverables of the assigned product(s). Negotiation skills: Demonstrates strong negotiation skills in collaborating with cross-functional teams, and stakeholders, aligning diverse perspectives, and driving consensus to achieve project objectives.
