JOB INFORMATION JOB SUMMARY Oversee strategy relating to obtaining, managing and maintaining product Marketing Authorisations and support Clinical Trial Authorisations (where applicable) in line with business goals and legal requirements in partnership with above-country operational hubs. Under the guidance and supervision of line management, lead strategic regulatory activities for assigned products and markets, and contribute to the implementation and leadership of projects and building expertise within the cluster regulatory team. Support line management to make decisions that require developing innovative solutions to resolve complex problems. Management of contractors (where applicable). JOB RESPONSIBILITIES Deliver Regulatory Strategy and Advise Cross-Functional Teams In line with assigned product and country responsibilities, utilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for both licensed and development products. Represent Regulatory on cross-functional product teams and provide strategic regulatory input to the commercial operating planning process. Facilitate cross-functional awareness and understanding of regulatory issues and environment, including ensuring teams understand the potential opportunities and constraints that the latest legislation/upcoming changes to legislation might create for their commercial activities. Keep cross-functional colleagues and key stakeholders informed of progress with regulatory submissions. Work with above country strategists to provide country input into Global and Regional regulatory strategies as required. Build personal expertise through management of assigned products within one or more therapy areas and one or more countries. Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests. Use expert knowledge of national legislation, guidelines and regulatory environment to provide insightful responses to enquiries from cross-divisional Pfizer colleagues and indirect interactions with external customers. Advise on matters of compliance, national regulatory requirements and Pfizer regulatory policy. Use a variety of communication tools and techniques to present complex ideas. Anticipate potential objections and influence others. Manage New Registration/Marketing Authorisation Applications: National Applications Coordinate pre-submission meetings and other National Regulatory Authority (NRA) engagements, such as EU national Scientific Advice Meetings. Devise and obtain endorsement for submission strategy and plan and partner with above-country operational hubs and above-country strategists to obtain new product licenses. Manage associated interactions and negotiations with NRAs. Manage Marketing Authorisation (MA) Variation Applications Trigger locally driven submission demands (e.g. NRA queries and requests for local label updates). Input to assessing regulatory impact, agree filing strategy with other business functions as appropriate and participate in risk-based reviews with above-country hubs and communicate any locally triggered delays & risks impacting the submission/approval, to the above and in-country stakeholders. Work with above-country strategists and above-country operational hubs to supply country documentation/information for dossier build as applicable. Communicate NRA decisions to relevant internal stakeholders as applicable. Manage MA Renewal Applications Agree filing strategy with relevant stakeholders as appropriate and participate in risk-based reviews of plans with above country hubs. Management of NRA queries In partnership with above-country operational hubs and above-country strategists, respond to NRA queries. External Relationships Proactively take opportunities to develop or enhance working relationships with Regulatory Authorities and trade associations. Develop and enact appropriate influencing strategies in order to negotiate optimal outcomes for the business on product issues. Utilise knowledge of NRA’s expectations, ways of working etc. to appropriately direct company strategy. Share updates and regulatory intelligence with colleagues. Seek authority advice/clarification if regulatory position unclear and answers are not available through internal network. Respond to spontaneous requests from authorities promptly and accurately. Work with authorities if Pfizer position differs from authority position to obtain a better outcome for the business/patients. Populate and Maintain Regulatory Databases Perform database entry and the document management for regulatory transactions undertaken by Country Regulatory Strategists, in line with global SOPs. Safeguard Compliance in the Management of Packaging and Prescribing Information Component updates Via defined procedures notify relevant internal stakeholders of NRA approval of changes to packaging components and prescribing information and the timelines for associated implementation activities. Negotiate extensions to packaging artwork implementation with Regulatory Authorities when applicable. Support MA Divestments, MA Cancellations, product Discontinuations and Supply Continuity Working with local stakeholders and above country operational Hubs, where applicable: Divestments: Advise business on regulatory activities required prior to divestment/transfer of licence. Support licence transfer. Discontinuations: Liaise with local Commercial/Medical/Demand functions and advise on regulatory action required for discontinuation of a product in the country marketplace. Upon receipt of above-county endorsement to proceed, trigger applicable notification to NRA and other external stakeholders as required by national regulations. Cancellations : Upon receipt of in and above-county endorsement to proceed, manage applicable notification/request to NRA, as required by national regulations. Notify relevant colleagues of approval of the licence cancellation. Interruptions to Supply: Notify Regulatory Authorities of interruptions to supply in accord with national regulations and as agreed with cross functional team. Work with cross functional team to explore options to help minimise or mitigate the out of stock. Obtain the necessary NRA approval as required and partner with above-country Operational Hubs as applicable. Support Third Party Licences Manage relevant, local regulatory activities related to supporting third party licences for which Pfizer has a contractual obligation, in accord with applicable business agreements and Pfizer SOPs. Devices Support regulatory activities for the development and maintenance of medical devices if required. Contribute to Good Regulatory Practice (GRP) Adhere to relevant procedures and practices (SOPs, Job Aids and WIs) to ensure GRP is maintained. Help identify changes to business processes to improve them as necessary, including to reflect changes in regulations. Lead by example, guiding more junior colleagues in relation to best practice and required procedures. Through maintenance of regulatory activities in line with company procedures for own products, contribute to “inspection ready” state. Support Regulatory Group Development Contribute to and support as necessary, the maintenance and development of the cluster/country Regulatory team through pro-active involvement and participation and in some instances, leading of special projects; e.g. development of new operating procedures. Support drive towards Pfizer and GRS Vision and Values. Support development of regulatory colleagues by sharing relevant knowledge and experience. Lead Personal Development and support coaching/mentoring of team members Identify own training and development needs in discussion with Manager to ensure a broadening skill and knowledge base and to maximise/optimise career development and contribution to the business. Develop product and therapeutic area knowledge as needed, according to product responsibilities list. With support of Manager build on competency strengths and address any development areas. Act as a senior mentor/coach for less experienced colleagues. Cluster & Project Management To take responsibility for identifying, implementing and managing key Regulatory Cluster projects either on an individual basis or as part of the Cluster leadership team, based on both short and long termCluster objectives including agreement of relative project priorities with Head of Cluster, as appropriate. To play a leading role in ensuring that the Cluster has effective and efficient processes in place. To participate in/lead, cross-functional project teams, to address business needs in line with Global/Regional GRS and Cluster business objectives and strategic imperatives. To create an environment where innovation is the standard and take appropriate risks to advance innovative processes and methodologies based on comprehensive business knowledge. To interpret internal/external business and regulatory challenges and best practices to recommend improvements to products, processes, or services. To monitor strategic regulatory activities across product therapy areas and assist with the management of projects as necessary to ensure compliance with NRA and corporate requirements and timelines. Regulatory Team Support Oversee any assigned contractors to achieve agreed objectives, with high quality outputs, and to identify and address training and development needs. Ensure any assigned contractors are supported and that they have a manageable workload through redistribution, prioritisation or outsourcing of work, as necessary, including planning of appropriate timelines and resource allocation. Include consideration of individual strengths when allocating project/product responsibilities. Ensure regulatory team members work effectively in a productive and well-motivated environment through providing ongoing coaching, mentoring, guidance and sharing of regulatory expertise. Regularly takes informal leadership role during Team meetings to facilitate agreements and move the team toward its goals. May take responsibility for a portion of the team’s milestones/deliverables. Support the recruitment of new staff as required. Ensure systems are in place and adhered to for optimal process efficiency. QUALIFICATIONS / SKILLS Life sciences or chemistry graduate to honours level or equivalent Masters Degree, Post Graduate Diploma or PhD preferred Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory) Previous experience and proven track record in Regulatory (Human Medicinal Products) Computer literacy Excellent written and verbal communication skills Proven strength in analytical thinking Leadership capability Work location assignment: Hybrid (some office presence is required) 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