Associate Director, AI-Driven Regulatory CMC

Merck; Rahway (NJ); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

401(k)

Medical insurance

Dental insurance

Vision insurance

Paid time off

Job summary

Merck is seeking an Associate Principal Scientist, Regulatory CMC Digital Innovation to drive AI-enabled authoring and digital transformation across Regulatory CMC workflows. The role partners with Regulatory CMC, R&D, and Manufacturing to implement integrated AI solutions that enhance productivity and compliance.

The position reports to the Executive Director of Regulatory CMC Digital Innovation and requires strong experience in Regulatory CMC, digital tools, and change management, with up to

Qualifications

• Minimum BS or equivalent Scientific, Technical, or Regulatory degree (focus on chemistry, biology, pharmacy, computer science, or data analytics preferred).
• Minimum of five (5) years of experience in the pharmaceutical or biotech industry, with a strong background in Regulatory CMC, Regulatory Affairs, or related pharmaceutical technical operations.
• Hands-on experience developing, implementing, or optimizing digital tools, automation, and modern AI/LLM solutions in a regulated business setting.
• Experience delivering enterprise-wide solutions that improve business outcomes.
• Experience in technical change management, with a capability to design repeatability assessments, job aids, and training materials for end-users.
• Experience mentoring and coaching colleagues or interns on digital projects and technical workflows.
• Strong collaboration and communication skills, with a proven ability to work effectively in a matrix environment across various functional units (such as research, manufacturing, and IT).
• Up to 10% Travel.

Responsibilities

• AI-Enabled Authoring & Innovation: Drive the advancement of AI-enabled regulatory authoring capabilities (including Module 2/3 authoring innovations).
• Emerging Tech Advocacy: Stay abreast of rapid tech advancements and assess their utility for Regulatory CMC processes.
• Cross-Functional Collaboration: Lead cross-functional activities related to AI authoring, automation, regulatory intelligence, and digital transformation.
• Digital Operating Model Support: Help establish and embed the CMC digital/AI operating model across enterprise strategies.
• Partner with Regulatory CMC Systems/Operations to develop digital solutions for regulatory platforms (e.g., Veeva).
• Application Ownership & Reporting: Be the primary Regulatory CMC contact for key digital tools and tracking progress.
• R&D/Manufacturing Partnerships: Work across divisions to identify joint digital opportunities and data handoffs.
• Advocacy & Change Management: Champion enterprise-wide AI adoption and drive training activities.
• Mentorship & Community Building: Guide digital project teams and foster AI/Digital Enablement collaboration.

Skills

Change Management

Collaboration

eCTD

Emerging Technologies

Regulatory CMC

Regulatory Affairs

Regulatory Compliance

Regulatory Reporting

Regulatory Strategy Development

Regulatory Submissions

Education

BS or equivalent degree (scientific/technical/regulatory)

Tools

ERA App

Veeva

Job description

Merck is seeking an Associate Principal Scientist, Regulatory CMC Digital Innovation to drive AI-enabled authoring and digital transformation across Regulatory CMC workflows. The role partners with Regulatory CMC, R&D, and Manufacturing to implement integrated AI solutions that enhance productivity and compliance.

The position reports to the Executive Director of Regulatory CMC Digital Innovation and requires strong experience in Regulatory CMC, digital tools, and change management, with up to