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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory data management, informatics analytics, and enterprise data systems, with a strong focus on delivering compliant and scalable digital solutions. Proven ability to lead cross-functional teams and drive strategic initiatives that enhance operational efficiency and data quality.
Highest-signal resume keywords
Regulatory Data ManagementData IntegrityEnterprise Data SystemsLeadership in Digital TransformationAnalytical Laboratory Expertise
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data ManagementInformatics AnalyticsEnterprise Data PlatformsRegulatory SubmissionsQuality SystemsLaboratory OperationsDigital Capabilities DevelopmentAdvanced AnalyticsAI/GenAI KnowledgeProblem-Solving
Soft Skills
People LeadershipStakeholder ManagementCross-Functional InfluenceStrategic ThinkingChange Leadership
Industry Keywords
INDNDA/BLARegulated EnvironmentOperational EfficiencyContinuous ImprovementData QualityDigital TransformationScientific InnovationComplianceInspection-Ready Solutions
About the role
Key responsibilities & impact- Lead an integrated organization supporting regulatory data management, informatics analytics, and enterprise data system capabilities
- Deliver accurate, traceable, and submission-ready regulatory data across the product lifecycle from IND and NDA/BLA through post-approval filings
- Advance scalable analytics, visualization, and self-service data solutions for product monitoring, operational transparency, insights, and data-driven decisions
- Serve as business owner or representative for enterprise data systems, driving strategy, governance, enhancements, adoption, and business value
- Translate scientific, regulatory, quality, and business needs into scalable digital capabilities and data solutions
- Partner across Analytical Development, Regulatory CMC, Quality, Digital, Research & Development, Manufacturing, scientific, regulatory, quality, and technology organizations
- Drive standardization, automation, and continuous improvement to improve data quality, traceability, and operational efficiency
- Ensure solutions are compliant, inspection-ready, scalable, and aligned with enterprise data and digital strategies
- Build and lead a high-performing team that accelerates scientific innovation and digital transformation
Requirements
What you’ll need- Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biology, Data Science, Statistics, Computer Science, Engineering, or related discipline with at least fifteen (15) years of relevant experience; OR Master’s degree with at least ten (10) years; OR Ph.D. with at least seven (7) years
- Proven leadership of data management, informatics, analytics, laboratory systems, enterprise data platforms, or digital transformation initiatives in a regulated environment
- Strong people leadership, stakeholder management, and cross-functional influence skills
- Working knowledge of data integrity, regulatory requirements, quality systems, laboratory operations, and enterprise system lifecycle management
- Strong strategic thinking, business acumen, change leadership, stakeholder engagement, execution, and problem-solving skills
- Experience managing diverse teams of scientists, contractors, and cross-functional contributors preferred
- Experience supporting regulatory submissions and post-filing activities from IND through NDA/BLA preferred
- Experience applying analytical laboratory expertise across development, stability, quality, and regulatory workflows preferred
- Experience serving as a business owner or product owner for enterprise systems, digital products, or data capabilities preferred
- Knowledge of AI/GenAI, advanced analytics, or emerging digital technologies preferred
- Experience delivering trusted, compliant, and inspection-ready scientific and regulatory data preferred
- Ability to develop scalable digital capabilities preferred
- No visa sponsorship
- US and Puerto Rico residents only
- Valid driving license is not required
Benefits
Comp & perks- Annual bonus
- Long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Hybrid work arrangement
- Domestic relocation
- 10% travel