Assoc. Dir, Regulatory Affairs-CMC
Merck · Rahway, NJ +1 more
The apply link worked recently (not employer-confirmed).
Role summary
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.
Where this listing comes from
This listing was compiled by RoleLantern from the employer's publicly available posting on Workday, captured and rephrased by RoleLantern using automated (AI) tools on 2026-10-04 (originally posted 2026-09-15). It was not submitted or confirmed by the employer through RoleLantern. Details may be inaccurate, incomplete, outdated, or no longer available; please confirm with the employer's official posting before applying.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
This role links to Merck's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.