Regulatory CMC Digital Innovation Lead

MSD Malaysia; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical

Dental

401(k)

Paid holidays

Vacation

Job summary

Merck & Co., Inc. in Rahway, NJ (or West Point, PA) seeks an Associate Principal Scientist for Regulatory CMC Digital Innovation.

The role focuses on developing digital and AI tools to improve regulatory workflows and drive enterprise alignment across GRACS and beyond. Responsibilities include driving AI-enabled authoring, evaluating new technologies, coordinating cross-functional initiatives, and mentoring teams to adopt digital solutions, while supporting regulatory platforms like Veeva and

Qualifications

• Minimum BS or equivalent degree in scientific/technical/regulatory field.
• 5+ years in pharma/biotech with Regulatory CMC/Regulatory Affairs experience.
• Experience delivering enterprise-wide digital solutions in a regulated setting.

Responsibilities

• Drive AI-enabled regulatory authoring and innovation, including Module 2/3 authoring.
• Evaluate emerging technologies for Regulatory CMC processes.
• Lead cross-functional AI projects and digital transformation initiatives.
• Support digital operating model alignment with enterprise strategies.

Skills

AI/ML in Regulated

Regulatory CMC

Cross-functional leadership

Digital tools

Education

BS or equivalent in scientific/technical/regulatory

Tools

Veeva

ERA App

Job description

Merck & Co., Inc. in Rahway, NJ (or West Point, PA) seeks an Associate Principal Scientist for Regulatory CMC Digital Innovation.

The role focuses on developing digital and AI tools to improve regulatory workflows and drive enterprise alignment across GRACS and beyond. Responsibilities include driving AI-enabled authoring, evaluating new technologies, coordinating cross-functional initiatives, and mentoring teams to adopt digital solutions, while supporting regulatory platforms like Veeva and