Job Summary

　　Report to Head, Regulatory Data & Conformance Management (RDCM) with direct and matrix management people responsibilities to manage Pfizer's Regulatory Data and Conformance activities within the Global Regulatory Sciences-Global Regulatory Operations (GRS-GRO) group.

　　Accountable for the oversight & execution of global data management activities spanning multiple regions, products etc. in support of new and remediation activities. Also accountable for the overall integrity and quality of Pfizer Global regulatory data through the oversight of data quality, completeness and timeliness, working in close partnership with the relevant BPO's to inform procedural and process updates.

　　Accountable for measuring, experimenting and driving RDCM & GRS towards data excellence through innovation and improvement, utilizing existing and new capabilities such as AI, automations and reports in support of optimizing data quality and efficiencies for GRS.

　　This role will also be responsible for completing, overseeing, or supporting strategic initiatives identified by GRS in support of progressing/evolving GRS Data management. Typical projects can include working on business transformation, implementing change management, building new capabilities, increasing business efficiency efforts, re-designing complex processes or working on program management efforts for global/regional projects.

　　Finally, this role is responsible for liaising and influencing partner lines in the interest of safeguarding patient safety through high quality data management across Pfizer systems.

　　Job Responsibilities

　　Key Accountabilities:

　　Accountable for the oversight of global data management activities and stewardship of Regulatory Milestones and license status conformance within regulatory systemsLead a team of global resources that are a blend of FTEs/Vendors/Contractors across multiple time zonesChampion innovation and takes appropriate risks to challenge the status quo, resulting in enhanced processes that impact the business directions of cross functional teams and Business UnitsInfluences senior management decisions that have an impact on business direction to support global regulatory data strategies across all global business units and marketsLead the evolution of data management & quality oversight in partnership with business, IM and digital partnersEnsures overall data integrity through audit and verification checks, performing quality control of timeliness, accuracy and completeness of data.Develop key performance indicators in order to ensure accurate and timely execution of improvement initiatives and guarantee increased compliance in relevant processes.Liaise with business process owners, ensuring interpretations of compliance requirements and as a key stakeholder providing inputEstablish effective and open communication with all relevant stakeholders to ensure appropriate staffing and coverageCoach, mentor and develop staff, including overseeing new employee onboarding and providing career development planning and opportunitiesDemonstrated ability to effectively lead cross-functional teams and to autonomously influence business decisions where direct reporting line relationships do not exist.Ability to autonomously influence business decisions where direct reporting line relationships do not exist.Efficient use of resources through operational effectiveness.In Partnership with GRO stakeholders, e.g., business process owners, SM, Strategists, serve and co-ordinate regulatory compliance activities ensuring the timely delivery of all regulatory compliance activities across the portfolio.

　　Qualifications / Skills

　　Master's or Undergraduate degree plus relevant experience desiredKnowledge of pharmaceutical business, including drug development and regulatory aspectsRegulatory Expertise: Demonstrated knowledge of Regulatory compliance requirements, processes, and systemsA strong understanding of technical requirements for tracking regulatory milestones as defined by FDA, EMA, MHLW, ICH, and regional marketsUses a variety of communication tools and techniques to present complex ideasWorks independently on most assignments using knowledge and work experience to achieve desired resultsOperates independently in ambiguous situations within Sub Business Unit/Sub Operating Unit; decisions may directly affect Sub Business Unit/Sub Operating Unit ability to deliver its objectivesAnticipates internal/external business and regulatory/ compliance issues that impact the Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating UnitServesas advisor to others across Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating UnitArticulate with strong analytical and interpersonal skillsAbility to embrace innovative technologies and process and drive implementation remotelyProven aptitude in project management and process redesignAbility to lead others locally and remotelyStrong Project Managements Skills: Mastery of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines.Ability to influence internally to Pfizer and engage with industry colleagues and regulatory authorities in the external environmentAbility to streamline and manage a diverse set of processesAbility to manage a significant and diverse portfolio of work with cross-site and line teams.Technology: Experience with publishing software, XML, Document Management, regulatory milestone reporting tools

　　Work Location Assignment: On Premise

　　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

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