Director of Regulatory Data & Informatics

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

Job summary

Merck seeks a Director to lead regulatory data management, informatics, and enterprise data systems across the IND through NDA/BLA lifecycle, enabling scalable analytics and compliant data delivery.

You will partner with Analytical Development, Regulatory CMC, Quality, Digital, and R&D to build a high-performing team and digital capabilities that drive data-driven decisions.

Hybrid work options are available in supported U.S. locations and candidates with relocation may be considered.

Qualifications

• Bachelor’s degree and 15+ years in analytical development, chemistry or regulatory data domains
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Responsibilities

• 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 (IND to post-approval).
• Advance scalable analytics and self-service data solutions for proactive product monitoring and informed decisions.
• Serve as business owner for enterprise data systems, driving strategy, governance, and adoption.
• Translate scientific and regulatory needs into scalable digital capabilities and data solutions.
• Partner across scientific, regulatory, quality, and technology to deliver scalable, compliant solutions.
• Drive standardization, automation, and continuous improvement to data quality and efficiency.
• Ensure solutions are inspection-ready and aligned with enterprise data 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

Ph.D.

Tools

Enterprise data platforms

Job description

Merck seeks a Director to lead regulatory data management, informatics, and enterprise data systems across the IND through NDA/BLA lifecycle, enabling scalable analytics and compliant data delivery.

You will partner with Analytical Development, Regulatory CMC, Quality, Digital, and R&D to build a high-performing team and digital capabilities that drive data-driven decisions.

Hybrid work options are available in supported U.S. locations and candidates with relocation may be considered.