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.
• Ensure all in scope activities for assigned products are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
• Lead collaboration across other Data Vanguard TA Leads effectively communicating ideas for process optimization, compliance enhancements and consistent resolution of common issues across TA’s to ensure aligned approaches to regulatory strategies and/or policies and procedures.
• Promote a culture aligned with Pfizer values by contributing to global, regional and/or local regulatory initiatives, compliance, innovation, and talent development.
• Manage team workload, optimize resource allocation, and ensure business continuity through proactive collaboration with other Leads and partner/stakeholder leadership teams (LT).
• Support professional development by guiding, coaching, mentoring, and providing feedback to foster individual growth and continuous learning on agency requirements and regulatory processes.
• Liaise with internal stakeholders to address issues related to data, standards and processes, supporting the development and maintenance of documented procedures and guidelines.
• Ensure the evolution of the service model based on strategic objectives – efficiency/quality driver
• Serve as a major source of innovative ideas seeking future efficiencies and effectiveness whilst formulating new common optimized processes in support of products through the development and commercial Lifecyle of a drug

QUALIFICATIONS / SKILLS

• Bachelor’s or Master’s degree, preferably in Life Sciences, Regulatory Affairs, Data Management, or related field.
• 8+ years of experience in Regulatory Affairs or Regulatory Operations, with at least 2 years in a data governance, data management, or data quality/compliance role.

• 3+years management & supervisory experience in a regulatory field managing global and/or local resources & resource capacity algorithms
• Managing the Organization: Demonstrated experience in support of large change programs involving x-site teams and perspectives (people, project and portfolio based). Ability to mobilize resources at short notice, and operate as a clear decision maker
• Business Perspective: Cross functional, Global perspective within the context of business needs and impact. Must have demonstrated business acumen; strong organizational management skills, the ability to handle multiple demands simultaneously; the ability to respond to tight timelines; as well as the capability to interact with all levels of the organization in a professional and discrete manner
• Fluent in English
• Skilled in managing significant scale of portfolio of work, and load balance across different locations/geographies/time zones
• Influencing & change agent skills that can exhibit regulatory knowledge and understanding, technical competence, sound judgment, and a professional demeanor
• Proven ability to influence and lead cross-functional teams without direct authority.
• Robust understanding of biopharmaceutical industry, regulatory and safety processes, external/internal environment
• Strong understanding of global regulatory submission and compliance requirements.
• Detailed understanding of regulatory system structures and how they are intended to enable regulatory business needs ​and support compliance (e.g., Veeva RIM, Liquent, Lorenz).
• Detailed understanding of regulatory SME processes and needs across the lifecycle, e.g. centralized registration procedures, IDMP, CMC, Artwork/Labelling
• Strong understanding of data governance principles and best practices, certification in data management or data governance a plus(e.g., ISO IDMP, xEVMPD, SPL).
• Decisions impact Sub Business Unit/Sub Operating Unit and its customers
• Anticipates internal/external business and regulatory/ compliance issues that impact the Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating Unit
• Technical Expertise: Demonstrated knowledge of / experience with strategic business planning and operations
• Communications Skills: Ability to communicate complex information and analyses, and difficult messages, to a variety of audiences in both verbal and written format
• Deals with Ambiguity; Creativity; Ability to Adapt in Real-Time
• Accountable for creating an environment where continuous improvement and innovation are embedded in daily operations
• Develops and fosters communities of practice and culture of inclusion

ORGANIZATIONAL RELATIONSHIPS

• Regulatory & CMC Strategy, Clinical, Non-Clinical, Labelling Data Coordinators, RIO, Digital
• Will work in a highly matrixed environment and in close collaboration with Operations and Strategy.

RESOURCES MANAGED

Summary of resources managed.

• FTE and/or vendor Data Stewards, Data Coordinators across global regions

 
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Regulatory Affairs