Use Your Power for Purpose
We are committed to bringing medicines to the world at a faster pace without compromising on excellence and integrity. Navigating the ever‑changing regulatory environment compliantly requires forward‑thinking and meticulous attention to detail. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer medicines and vaccines.
What You Will Achieve
In this role, you will be responsible for:
- Pfizer Reference Label management across therapeutic areas;
- Labeling/Artwork Systems and Data:
- Support the compilation of data from various sources, generate, and maintain dashboards, business scorecards, and reports. Influence decision‑making through data‑driven insights and stakeholder engagement.
- Investigate new technologies that enable better business efficiency, champion system changes, and adoption.
- Work across all necessary stakeholders within and outside GRS to align business needs and expectations to technologies and long‑term technology roadmaps.
- Contribute to designing and building system user requirements, reviewing configuration specifications, and resolving system record investigations.
- Contribute as a member of system change control boards and impact resolution teams and lead business discussions regarding specific projects and priorities.
- Lead process development by translating business requirements into current and future business processes.
- Keep informed of industry labeling/artwork trends and evaluate against and for Pfizer best practice.
- Acquisitions, Collaborations & Divestitures Coordination:
- Serve as the primary point of contact for label exchange activities under Pharmacovigilance Agreements.
- Coordinate timely and compliant exchange of labeling information with external partners.
- Monitor and resolve discrepancies, ensuring alignment with safety and regulatory commitments.
- Lead labeling‑related activities during acquisitions and divestitures, including due diligence and integration planning.
- Act as the central liaison between internal teams and external stakeholders to ensure seamless transitions.
- Develop and execute labeling strategies that support business continuity and compliance.
- Labeling Intelligence Management:
- Maintain the integrity and accuracy of the labeling and artwork pan‑portfolio intelligence data across applicable business and regulatory systems.
- Ensure proper data governance, version control, and metadata management.
- Coordinate the labeling universe maintenance process, including analysis and tracking of updates. Ensure regular data quality checks are performed and support the resolution of identified issues.
- Ensure correct label tracking strategies are implemented in the setup of new products, updated during the lifecycle of the product and the correct end of label maintenance activities are performed.
- May support one or more of the pan‑portfolio labeling intelligence processes including but not limited to …
- Maintenance of the Regulatory Requirements Database for international labeling;
- Single Reference Safety Document identification and management;
- Innovator Monitoring for the generic portfolio;
- North Star; Support audits and inspections by ensuring data readiness and traceability.
- Strategic Initiative Management:
- Provide strategic and operational support for high‑impact, cross‑portfolio initiatives.
- Lead or contribute to special projects that enhance labeling processes, systems, or compliance.
- Collaborate with global teams to drive innovation and continuous improvement.
- Provide project management support across labeling initiatives, ensuring timelines, resources, and deliverables are met.
Here Is What You Need (Minimum Requirements)
- Bachelor’s Degree or equivalent with 8+ years relevant experience in a global/multi‑national pharmaceutical environment, including direct experience in Labeling or Regulatory Affairs.
- Experience with Business Analytics required.
- Experience interacting autonomously with leaders and working in a matrix team environment a must.
- Experience interpreting and applying global and local regulatory guidance around labeling/regulatory and associated supportive documentation desirable.
- Ability to partner with a wide range of business stakeholders, crossing multiple divisions across multiple countries/cultures.
- Proven leadership driving highly complex projects to meet evolving business needs.
- Ability to manipulate and understand complex data.
- Mastery of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines.
- Clear and adaptive verbal and written communication skills.
Bonus Points If You Have (Preferred Requirements)
- Advanced academic qualification/degree desired; equivalent relevant professional experience will be considered.
- Strong problem‑solving skills and ability to develop new options in non‑standard situations.
- Excellent interpersonal skills and the ability to mentor and guide others.
- Strong facilitation and project management skills.
- Excellent knowledge of tools used to design processes and process flows.
- Knowledge and experience with labeling or similar tracking systems.
- Knowledge of XML, regulatory tracking, document management systems, various reporting tools.
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.
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 transforming millions of lives.
Digital Transformation Strategy
We are leading the way in adopting new data, modelling and automated solutions to digitize and accelerate drug discovery and development, enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture encouraging employees to achieve work‑life harmony, attract talent and enable everyone to be their best working self.
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial. As an employer, Pfizer is committed to celebrating diversity in all its forms, enabling our workforce to be as diverse as the patients and communities we serve.
DisAbility Confident
We are proud to be a Disability Confident Employer and encourage you to put your best self forward with the knowledge and trust that we will make reasonable adjustments to support your application and future career. Our mission is unleashing the power of our people.
Regulatory Affairs
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