The International Labeling Team Lead (LTL) role is accountable for overseeing day-to-day planning, implementation, and problem solving activities for a team of Hub Labeling Managers (HLMs) whom are responsible for a cluster of assigned markets within a region. The LTL role reports to the respective Regional Labeling Head. The LTL ensures that content management of Local Product Documents (LPDs), Local Language Documents (LLDs) and Patient Leaflets for nationally registered products for their assigned clusters are handled by the HLMs according to company policies and SOPs, and that regionally-set compliance targets are met on a monthly basis. The LTL may also manage label updates themselves as and when required according to business need. The LTL is a subject matter expert for local labeling and acts as a resource to the Regional Labeling Head and other HLMs throughout the organisation, leading others in complex labeling projects or initiatives, and contributing to the use and development of current and new tools, technologies and processes to support global label development, submission and approval. Contribution to regional global knowledge resources is also a key part of the role, and the LTL is proactive in gathering, assessing and disseminating regulatory intelligence for use by HLMs and Regional Labeling Heads, as well as for use in strategic decision-making at the global group level. JOB RESPONSIBILITIES Provides management and oversight of assigned staff, setting goals in line with departmental and divisional goals, and ensuring each direct report has an Individual Development Plan. Acts as the key escalation point with PCO Regulatory Heads when a labeling-related issue cannot be resolved by the assigned HLM. Mentors, trains or supervises assigned HLMs in their day-to-day activities, reviewing their work where needed and providing expert advice on labeling content and process adherence. Is a critical reviewer of content in the Regulatory Requirements Database, ensuring that such content is accurate, comprehensive, and written in a way to enable effective comparison across markets. Actively fosters a culture of openness, creativity, engagement and behaviors in line with the Pfizer values. According to business need, utilizes regulatory expertise to review, develop and deliver core labeling documents such as the LPD and Patient Leaflet to support submissions to the Regulatory Authorities across regions, requesting medical advice or input from others when appropriate. The full range of labeling documentation may be produced, including labels for NCEs or Product Extensions, as well as complex revisions. Supports responses to inquiries from Pfizer colleagues in response to inspection activities and regulatory agency questions, and represent Pfizer during HA Inspections. Coordinates complex labeling activities when there is a regional, global or therapeutic area impact across multiple countries. Provides RLL with regular status reports on team progress against goals. May lead regional SME forums on labeling processes and clearly articulate expectations of the labeling process to a broad range of stakeholders. Interprets internal/external business challenges and best practices to recommend improvements to products, processes, or services. Takes appropriate risks to advance innovative processes and methodologies based on comprehensive business knowledge. May represent the function or region on project improvement initiatives. Meets strategic targets for labeling deliverables as defined for the function, and communicates progress against these targets and issues which could impact meeting these targets, including proposed remediation. Contributes to group targets, and proactively feeds back issues and roadblocks to senior management. Assist Regional Labeling Head in data analysis responsibilities – addressing requests for workload forecasts and incidence of certain situations within the region. May be appointed as a focal point within a Hub to lead compliance monitoring initiatives – alerting HLMs to specific items that need to be addressed and as the point of contact to investigate and escalate broader issues to the appropriate contact (Information Management or Process & Compliance Leads). Provide Hub representation for support during market audits and assistance in remediation proposals and activities. QUALIFICATIONS / SKILLS Leadership and motivational skills Excellent interpersonal skills to keep the team focused and on track for meeting their deliverables Comprehensive knowledge of the principles, concepts and theoriesof the discipline, and good understanding/ knowledge of principles and concepts of other labeling-related disciplines. Understands and applies labeling regulation in the region and in assigned local countries, and is able to interpret impact of that regulation on development of labeling text. Is aware of forthcoming changes in regulation and legislation and the impact on labeling deliverables, EU specific experience required. Proficient in use of systems consistent with business expectations, and understands importance of systems in maintaining target compliance figures Fluency in English language important however multi-language skills are advantageous Clear and effective written and verbal communications Understanding of the importance of Standard Operating Procedures (SOPs), systems and processes in underpinning quality and compliance of deliverables Education: Life sciences, pharmacy graduate or equivalent. Advanced academic qualifications/degree such as PhD an advantage but not essential. Experience: Direct management experience is preferred. Extensive ‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Sciences (Human Medicinal Products); preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a CDS on CLDs. Proven ability to successfully understand regulatory implications of product strategy with regard to the produce label, assessment and practical management of associated impacts. Demonstrated ability to interpret and apply regional/local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations. Knowledge of global/regional regulatory guidelines and requirements important Knowledge of Clinical Variations preferred Proven strength in logical, analytical and writing ability essential Demonstrated project management, attention to detail and problem solving skills required. ORGANIZATIONAL RELATIONSHIPS: This position reports to the respective Regional Labeling Head in International Labeling, within the Global and International Labeling and Artwork organsiation in Global Regulatory Sciences. Other key interfaces include PCO Regulatory Heads, regional and local Medical contacts, Information Management, and customer/stakeholder groups in Above-Country labeling functions, International Labeling and other lines within GRS. Work Location Assignment: Flexible Purpose Breakthroughs that change patients' lives At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience. Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation! Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees. DisAbility Confident We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here! Regulatory Affairs