Director, Regulatory Data & Informatics Strategy

Merck; Rahway (NJ); Hybrid; USD 173,000 - 273,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck in Rahway, NJ is seeking a Director to lead regulatory data management, informatics, analytics, and enterprise data systems. The role collaborates across Analytical Development, Regulatory CMC, Quality, Digital, R&D, and Manufacturing to deliver trusted data across the lifecycle from IND through NDA/BLA.

You will build a high-performing team, drive standardization, automation, and scalable digital capabilities that improve data accessibility, compliance, and data-driven decisions, while

Qualifications

• 15+ years in analytical development, regulatory CMC, informatics, or related fields.
• Proven leadership of data management, analytics, or digital transformation in a regulated environment.
• Strong people leadership and cross-functional influence with measurable business impact.
• Knowledge of data integrity, regulatory requirements, quality systems, and enterprise lifecycle management.
• Strategic thinking and change leadership with data-driven decision making.

Responsibilities

• Lead an integrated org for regulatory data management, analytics, and enterprise data systems.
• Deliver submission-ready regulatory data across IND through post-approval activities.
• Advance scalable analytics, self-service data solutions, and proactive product monitoring.
• Own or represent enterprise data systems, driving strategy, governance, and adoption.
• Translate scientific and regulatory needs into scalable digital capabilities.
• Collaborate to deliver compliant, scalable, and inspection-ready solutions.
• Drive standardization and automation to improve data quality and efficiency.
• Ensure alignment with enterprise data and digital strategies.

Skills

Academic Presentations

Bioconjugation

Computational Chemistry

Creativity

Data Analysis

High-Throughput Experimentation

Organic Synthesis

Professional Networking

Project Leadership

Research Proposal Development

Scientific Leadership

Scientific Literature Search

Strategic Thinking

Structure Based Drug Design

Synthetic Chemistry

Education

Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biology, Data Science, Statistics, Computer Science, Engineering, or related discipline

Master’s degree with at least ten (10) years

Ph.D. with at least seven (7) years

Job description

Merck in Rahway, NJ is seeking a Director to lead regulatory data management, informatics, analytics, and enterprise data systems. The role collaborates across Analytical Development, Regulatory CMC, Quality, Digital, R&D, and Manufacturing to deliver trusted data across the lifecycle from IND through NDA/BLA.

You will build a high-performing team, drive standardization, automation, and scalable digital capabilities that improve data accessibility, compliance, and data-driven decisions, while