The GCP Process Lead is responsible for identifying new or revised legislation / regulation/ guidance relating to Good Clinical Practice (GCP), assessment of potential impacts of regulatory changes on Pfizer GCP processes, triage management of regulatory information to appropriate stakeholders, and coordinating with them in order to mitigate impacts related to patient safety and well-being, reliability of trial results, and regulatory compliance. Serving as the SOP & Training (S&T) business contact for GCP regulatory intelligence. Identifying regulatory changes, industry trends, and internal Pfizer environments that potentially impact Pfizer GCP related processes to mitigate impacts related to patient safety and well-being, reliability of trial results, and regulatory compliance. Leading the operation of GCP Regulatory Intelligence Tracking tool (ClaRITA), collaborating with cross-functional senior leaders and appropriate subject matter experts (SMEs) for GCP regulatory monitoring, triaging, impact assessment, and following up until completion of the assessment. Assessing the impact of new/evolving regulatory guidances, providing insight and recommendations in collaboration with GCP business process owners (BPOs) and appropriate SMEs. Driving end-to-end business process for GCP regulatory monitoring, assessment, feedback loop, and oversight. Reporting results of impact assessment, regulatory trends, and overall key performance indicators to leadership teams and quality forums or governance as applicable. Coordinating cross-functionally with BPOs and appropriate SMEs to determine any relevant actions and actions owners as a result of regulatory impact to Pfizer GCP processes. Tracking actions to completions in Pfizer action tracker. As appropriate, engaging in the initiatives or activities of GCP Quality to ensure alignment in interpretation and dissemination of applicable regulations, guidance, and Pfizer policies and procedures to customers and stakeholders. As needed, coordinating comments on drafts/proposals on behalf of S&T, contributing to the overall Pfizer response. Maintaining appropriate level of expertise in regulatory requirements, Pfizer policies, SOPs and internal guideline applicable to clinical trial and quality processes. Partners with Process Quality Leads on coordination and support of Process Oversight Board. Qualifications: BS in a scientific or technical field of the disciplines related to drug development, quality, or regulatory compliance. Expert knowledge and understanding of GCP, regulatory interpretation and enforcement of GCP. Strong knowledge of regulatory requirements across a range of different countries and regions. Deep understanding of Clinical Research & Development in a pharmaceutical environment, clinical trial development and operational execution of clinical trials. Have experience related to comprehensive view of regulatory changes, trends, and potential impacts. Demonstrated experience engaging diverse stakeholder groups, senior leaders and establishing stakeholder relationships. Project management, administrative, and technical capabilities are required, as well as effective verbal and written communication skills. There are many stakeholders that this individual may interface with across functional lines and levels. Examples include: Supports S&T & GCP Quality on aspects of Regulatory Intelligence Partners with IM/Digital Technology on ClaRITA regulatory intelligence tool. Partners with stakeholders such as BPOs, local country SMEs, legal, regulatory etc on impact assessment and, as applicable, actions taken as a result of regulatory impact. Communicate/escalates to quality governance(s) on GCP quality trends, key performance results, etc. Work Location Assignment: Hybrid 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 Quality Assurance and Control