Assoc. Dir, Regulatory Affairs-CMC Job at Merck, North Wales, PA

  • Merck
  • North Wales, PA

Job Description

Associate Director role focused on developing digital and AI innovations across regulatory CMC workflows at a global pharmaceutical company. The position involves serving as a subject matter expert to help teams adopt digital tools, drive process automation, and support enterprise-wide digital transformation initiatives.

Responsibilities

  • Drive advancement of AI-enabled regulatory authoring capabilities and identify novel generative AI opportunities
  • Monitor emerging technologies and assess utility of AI, machine learning, and digital tools for CMC processes
  • Lead cross-functional activities for AI authoring, process automation, regulatory intelligence, and digital transformation
  • Establish and embed CMC digital/AI operating model aligned with broader enterprise digital strategies
  • Serve as primary point of contact for key digital tools and platforms, tracking progress and priorities

Requirements

  • Bachelor's degree in science, technical, regulatory, chemistry, biology, pharmacy, computer science, or data analytics
  • Minimum five years pharmaceutical or biotech industry experience in regulatory CMC or related operations
  • Hands-on experience developing, implementing, or optimizing digital tools and AI/LLM solutions in regulated settings
  • Demonstrated experience delivering enterprise-wide solutions that improve business outcomes
  • Experience designing technical change management materials, job aids, and training for end-users
  • Mentoring experience with colleagues or interns on digital projects and technical workflows
  • Strong collaboration and project coordination skills managing multiple overlapping initiatives in matrix environments

Job Tags

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