Lead Regulatory Affairs data analytics activities, including development of dashboards, reports, and performance metrics.
Analyze regulatory and compliance data to identify trends, risks, and opportunities for improvement.
Partner with Regulatory Affairs, Quality, IT, Project Management, and other business stakeholders to define data requirements and ensure data accuracy and integrity.
Provide inputs to and distill and interpret the information from the Strategy, Governance, and Insights team.
Understand the regulatory data, meanings of the data, and implications of the data to identify opportunities for Regulatory Affairs and support regulatory operations and leadership with insights to inform strategic and operational decisions.
Establish and maintain data governance standards, reporting frameworks, and analytics best practices.
Support audits, inspections, and internal reviews by providing accurate regulatory data and analysis.
Monitor evolving regulatory data and reporting requirements and assess impacts on analytics solutions.
Drive continuous improvement initiatives to enhance regulatory analytics capabilities and efficiency.
Requirements
Bachelor's degree in data Analytics, Information Systems, Regulatory Affairs, Business, Life Sciences, Engineering, or related discipline (required).
Advanced degree in Analytics, Data Science, Business, or related field (preferred).
Typically, 6-8 years of progressive experience in regulatory affairs, data analytics, reporting, or business intelligence within a regulated industry.
Experience developing dashboards, reports, analytics, and data and technical presentations to support regulatory or compliance functions.
Strong analytical skills with the ability to translate data into actionable insights.
Experience working with data visualization and analytics tools (e.g., SmartSheet, PowerBI).
Ability to manage complex data sets from multiple sources, insight to spot and resolve data conflicts, attention to detail to ensure data quality, and perspective to ensure data governance.
Familiarity with US, EU, and global regulatory processes and compliance metrics (preferred).
Experience leading or supporting regulatory submissions, audits, inspections, technical interactions, or reporting activities (preferred).
Experience working in a global or matrixed organization (preferred).
Demonstrated experience driving data or analytics process improvements (preferred).
Strong stakeholder management and communication skills (preferred).
Language: English required. German, French, Japanese, and Chinese a plus.
Benefits
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Vacation –120 hours per calendar year.
Sick time
40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year.
Holiday pay, including Floating Holidays –13 days per calendar year.
Work, Personal and Family Time
up to 40 hours per calendar year.
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child.
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year.
Caregiver Leave – 80 hours in a 52-week rolling period.
Volunteer Leave – 32 hours per calendar year.
Military Spouse Time-Off – 80 hours per calendar year.