Role Information
As a Manager, Regulatory Business Analyst within our Innovative Medicine division, you will bridge the gap between business stakeholders and technical teams. You will be responsible for analyzing, evaluating, and translating complex user requirements into high-impact digital solutions that align with global regulatory outcomes. This role is pivotal in driving the digital transformation of our Regulatory Affairs group, ensuring our life-saving medicines reach patients through efficient, compliant, and innovative submission processes.
Key Responsibilities
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Stakeholder Collaboration: Partner with business product leaders and technical teams to identify and drive optimal solutions grounded in agile and design thinking.
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Requirement Management: Translate product updates and user feedback into actionable business requirements and technical specifications.
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System Enhancement: Support ongoing improvements to Regulatory platforms (e.g., RIM, Veeva, Calyx) by prioritizing feature development and assessing change requests.
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Strategic Discovery: Engage in continuous research to identify market trends, emerging technologies, and evolving global compliance standards (FDA, EMA, ICH).
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Testing & Validation: Lead User Acceptance Testing (UAT) and system validation to ensure technical solutions meet defined business needs and quality standards.
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Process Optimization: Design end-to-end regulatory processes using GRA Process Office governance and establish KPIs for efficiency and user experience.
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Training & Advocacy: Act as a digital ambassador, providing user training and ensuring smooth adoption of new tools and workflows.
Qualifications
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Education: Bachelor’s degree in Business, Information Technology, Pharmacy, or a related field.
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Experience: Proven experience in business analysis within a regulated environment (Life Sciences/Healthcare preferred).
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Technical Skills: Deep knowledge of Regulatory Information Management (RIM) systems and analytical tools like Tableau.
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Methodology: Strong proficiency in Agile methodologies and Design Thinking principles.
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Communication: Exceptional ability to distill complex data into clear insights for diverse stakeholders.
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Leadership: Demonstrated ability to lead cross-functional teams in a fast-paced, matrixed environment.
To apply for this job please visit www.careers.jnj.com.
