5 Cluster Positions Available – Please indicate the cluster name you wish to be considered for when submitting your application: Central & Eastern Europe Cluster Western Europe Cluster Southern Europe & Israel Cluster Northern Europe Cluster ANZ & Korea Cluster REPORTS TO: Vice President, Head of International Regulatory Sciences Kimberly Location of Cluster Role: Central & Eastern Europe Cluster – Germany Western Europe Cluster – France or Belgium Southern Europe & Israel Cluster – Spain or Italy Northern Europe Cluster – UK or Sweden ANZ & Korea Cluster – Australia or South Korea ROLE SUMMARY Lead, manage and provide strategic direction to the cluster regulatory team located in primary and secondary markets. Accountable for all strategic regulatory activities for the cluster including pre- and post-authorisation product lifecycle activities and delivery of operational regulatory activities in partnership with above-country operational hubs. Deliver cluster/market strategic priorities and regulatory aspects of commercial operating plans to budget and support delivery of regional regulatory strategies and objectives. Provide regulatory guidance/input into global and regional product development and regulatory strategies. Accountable for effective relationships with National Regulatory Authorities (NRAs) across the cluster and representing the company at the regulatory committee(s) of the local Trade Association(s). ROLE RESPONSIBILITIES Leadership and Strategic Role: Lead and manage the cluster team located in primary and secondary markets in the development of regulatory strategies for registration of new products and line extensions, and their lifecycle management for all cluster markets, including markets without an IRS footprint. Ensure that the team provides input into global and regional development and regulatory strategies to provide optimal support for meeting regional and cluster/country business objectives. Through fungible country, portfolio and asset assignments to Country Regulatory Strategists in primary and secondary markets, drive strategic priorities and activities for cluster markets without an IRS footprint. Responsible for the leadership, development, and performance management of the cluster team to achieve company objectives and culture. Develop and enhance the capabilities and capacities of the team through the identification and implementation of training and development needs. Ensures that all regulatory activities in the cluster are managed in compliance with Pfizer standards and international/national regulations. Internal Partnerships: Develop strong partnerships within the cluster (e.g., Country Leadership Teams, Commercial, Medical, Safety, Supply Chain), and GRS functions including Global CMC, Operational Hubs and global/regional GRS and GRS Oncology Regulatory Strategy Leads and their teams to facilitate the development and implementation of regulatory strategies to expedite the registration of new products, line extensions and life-cycle optimization. Provide strategic contribution to the cluster Country Leadership Teams – anticipate what Regulatory needs to contribute to achieve business objectives, e.g., country and regional commercial Operating plans. Operational Excellence: Ensure internal regulatory processes and procedures are well documented and support compliant regulatory activities. Ensure licenses in the cluster are maintained (e.g., Marketing Authorizations) by Country Regulatory Strategists in partnership with Operational Hubs, as needed, in compliance with all relevant international and national regulations and internal policies, procedures, and processes, and ensure GRS systems are kept updated (e.g., CMC change control, product labelling, etc.). Clinical Trials (for clusters where clinical trials are or could be conducted and CTAs registered): Ensure cluster team support the following strategic clinical development activities in partnership with NRAs, Above Country Regulatory Strategists (AC RS) and Clinical Trials Regulatory Strategy Execution (CTRSE) as applicable: Optimization of Clinical Development Plan (CDP) and Country Footprint. Communications with NRAs to clarify questions during assessment as required by CTRSE Support Regulatory Requirements Manager (RRM) updates for local Clinical Trial Applications (CTAs) and study conduct requirements. Participation in national CTA Trade Association working groups and advocacy activities. Additionally for EU countries only: Selection of Reporting Member State (RMS) Support contact with RMS and Concerned Member State (CMS) National Regulatory Authorities as required for any scientific interaction at a program (Scientific Advice) or study level (Pre-CTA/Pre-vetting meetings). External Relationships: Responsible for developing and enhancing relationships with key external entities (e.g., NRAs, Regulatory Key Opinion Leaders (RKOLs), etc.). Manage the NRA interface throughout the product development and product lifecycle, developing a long-term and positive relationship characterized by Integrity, Quality, Compliance and Leadership. Representing the Company at NRA meetings. Directly accountable for NRA relationships in their local market and cluster markets without an IRS footprint and supports other their team in other cluster markets with their NRA relationships. Partner with Global and International Regulatory Policy to develop and reinforce Pfizer regulatory positions with external stakeholders and understanding of the external environment. Understand applicable international and national regulations and developing trends in the cluster markets regulatory environments and provide impact assessments to key stakeholders. Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business strategies, and decision making. Influence new legislation initiatives that could impact the business. Active participation in the national Trade Association(s) and effective communication with key stakeholders of issues that could impact regulatory strategies or the business. QUALIFICATIONS / SKILLS Scientific Degree – such as life sciences or chemistry. A pharmacy degree may be mandatory in some countries. A higher degree (MSc, MBA or PhD) may be an advantage but is not essential. Extensive experience of human medicines regulatory affairs. Proven ability to manage complex regulatory issues. Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution. Proven ability to consistently deliver to time, cost and quality standards. General management experience and previous line management and leadership experience at senior management level is essential. Demonstrable experience of effective delivery in a complex matrix environment. Strong leadership qualities and management skills, including talent development, teamworking, problem solving, communication and interpersonal skills. In-depth knowledge of international, regional and national regulatory legislation and guidelines applicable to the markets in their cluster. Strong understanding of business and financial environment, drug development process and the pharmaceutical industry. Knowledge and understanding of quality systems, processes, audit and inspections. Ability to influence at all levels in the organization and build networks internal and externally. ORGANIZATIONAL RELATIONSHIPS Reports to the Vice President, Head of International Regulatory Sciences. Member of the International Leadership Team. Member of the IDM Regulatory Strategy Group (IDM-RSG). Member of Country Leadership Team and Country Medical Council (CMC). External: National Regulatory Agencies for cluster countries. Cluster countries Trade association(s). Other local country national bodies. Internal: Commercial, Medical, Access and Value, Quality, Regulatory Law. Regulatory Operations, Global CMC, ALIM, PGS. Global and International Regulatory Policy, Legal, Finance. RESOURCES MANAGED Size of cluster Regulatory Sciences Team supporting markets across the cluster will vary from approx. 10-25 resources. 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