Regulatory Data Vanguard TA Lead

** JOB SUMMARY
** The Regulatory Data Vanguard Therapeutic Area (TA) Lead is accountable for leading a global team of data stewards and coordinators within Regulatory International Operations, in support of Global Regulatory Sciences (GRS). This role provides strategic direction, operational oversight, and cross-functional alignment for their assigned TA, working to ensure the accuracy & integrity of Pfizer’s master & registration data in addition to effective & compliant coordination of all change activities impacting Pfizer’s clinical & commercial portfolio.

With oversight of the day to day operations of a group of product aligned Data Stewards & Data Coordinators, the primary responsibilities spans Vault-RIM master data management, Identification of Medicinal Prodcuts (IDMP) data submissions, adherence to data standards, assessment of Regulatory Events for metadata impacts, and creation and set up/management of all related records (e.g, Event Details, Applications, Registrations, Activities, Regulatory Objectives, Submissions, Global Content Plans, etc) to enable proper downstream execution of regulatory activities by multiple functional lines throughout the regulatory continuum.

Note. Master data is crucial for regulatory & Pfizer because itensures the accuracy, consistency, and reliability of data used in regulatory submissions and compliance processes.

Accurate master data directly impacts the quality, safety, and efficacy of products, and any inconsistencies can lead to delayed approvals, product recalls, and regulatory penalties.

The TA Lead will serve as the primary interface with their CMC, Labelling, Above Country Strategy & Clinical counterparts as well as working with their peers across the Regulatory Data Vanguard team, to ensure the generation and maintenance of data in compliance with VAULT RIM processes all while ensuring efficient, quality execution.

The role demands significant experience and understanding of regulatory data, interdependencies within and across Vaults and its implications across the business to ensure product compliance. They support strategy implementation, bridging strategy and execution, and offer crucial insights and feedback at the strategic level.

The role will develop and monitor key KPIs in partnership with appliable regulatory functions and enterprise-wide Data Governance teams to ensure the quality, timeliness and compliant execution of Data Steward and Data Coordinator responsibilities while also evaluating opportunities to advance the digital landscape with Global Regulatory Sciences.
** JOB RESPONSIBILITIES
*** Maintains overall accountability for the accuracy and compliance of product master and event data for all products within their TA, leading a team of Data Stewards and Coordinators to work in strong partnership with key business stakeholders
* Oversight and management of people, technical resources and budget associated with TA aligned Regulatory Data Vanguard, across global locations and timezones.
* Foster strong working relationships with GRS and CMC LT leaders, forming part of their extended leadership teams as a key operational partner
* Lead Team delivering end to end data management and process execution for Commercial and Clinical products, from initial setup through to submission & decisions being accurately reflected and Regulatory Objectives closed.
* Demonstrate comprehensive knowledge of the Regulatory Continuum, Vault RIM functionality, process and system interdependencies.
* Play a leading role in the continued harmonisation of data standards and their application across Pfizer systems as part of a growing data centric culture.
* Partner with RIDGE to support the delivery of priority innovation programs, dependent on clean and accurate data.
* Lead open communication pathways with TA aligned Regulatory and CMC Strategy partners, including GRS Data Owners to ensure effective execution of end to end process deliverables and aligned expectations.
* Lead, coach, and manage direct reports, fostering development through training opportunities, performance feedback, and goal progress reviews, ensuring adherence to performance metrics.
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