Assoc. Dir, Regulatory Affairs-CMC
Merck
August 18, 2026
Remote friendly (Rahway, NJ)
United States
Corporate Functions
Associate Director, Regulatory CMC Digital Innovation
Responsibilities:
- Drive AI-enabled regulatory authoring capabilities (including Module 2/3 authoring innovations), develop practical job aids, and identify generative AI drafting opportunities.
- Stay current on emerging AI/ML and digital tools; assess utility for Regulatory CMC processes.
- Lead cross-functional work for AI authoring, process automation, regulatory intelligence, and digital transformation.
- Help establish, communicate, and embed the CMC digital/AI operating model to connect and scale localized efforts with enterprise strategies.
- Partner with Regulatory CMC Systems/Operations to develop digital solutions impacting regulatory platforms (e.g., Veeva) as needed.
- Serve as primary point of contact for key digital tools/platforms (e.g., ERA App) and support CMC digital priority tracking and progress reporting.
- Partner across Research & Development and Manufacturing to identify shared digital opportunities and ensure smooth data/process handoffs.
- Champion enterprise-wide AI adoption via champion networks, feedback loops, and change management/training.
- Propose, lead, and mentor digital project teams, including GRACS CMC summer intern projects.
Education:
- Minimum BS (or equivalent) in scientific/technical/regulatory field (chemistry, biology, pharmacy, computer science, or data analytics preferred).
Required Experience:
- 5+ years in pharma/biotech with strong Regulatory CMC/Regulatory Affairs or related technical operations.
- Hands-on experience developing/optimizing digital tools, automation, and AI/LLM solutions in regulated settings.
- Experience delivering enterprise-wide solutions improving business outcomes.
- Technical change management; create repeatability assessments, job aids, and end-user training materials.
- Mentoring/coaching colleagues or interns.
- Strong collaboration/communication in matrix environments; organizational and project coordination skills.
- Up to 10% travel.
Required Skills:
- Change management; collaboration; eCTD; emerging technologies; liaison work; project leadership; regulatory strategy/submissions/management/reporting; regulatory compliance/documents/experience.
Benefits:
- Eligible for annual bonus and long-term incentive (if applicable). Comprehensive benefits include medical/dental/vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Application deadline is stated on the posting.
Responsibilities:
- Drive AI-enabled regulatory authoring capabilities (including Module 2/3 authoring innovations), develop practical job aids, and identify generative AI drafting opportunities.
- Stay current on emerging AI/ML and digital tools; assess utility for Regulatory CMC processes.
- Lead cross-functional work for AI authoring, process automation, regulatory intelligence, and digital transformation.
- Help establish, communicate, and embed the CMC digital/AI operating model to connect and scale localized efforts with enterprise strategies.
- Partner with Regulatory CMC Systems/Operations to develop digital solutions impacting regulatory platforms (e.g., Veeva) as needed.
- Serve as primary point of contact for key digital tools/platforms (e.g., ERA App) and support CMC digital priority tracking and progress reporting.
- Partner across Research & Development and Manufacturing to identify shared digital opportunities and ensure smooth data/process handoffs.
- Champion enterprise-wide AI adoption via champion networks, feedback loops, and change management/training.
- Propose, lead, and mentor digital project teams, including GRACS CMC summer intern projects.
Education:
- Minimum BS (or equivalent) in scientific/technical/regulatory field (chemistry, biology, pharmacy, computer science, or data analytics preferred).
Required Experience:
- 5+ years in pharma/biotech with strong Regulatory CMC/Regulatory Affairs or related technical operations.
- Hands-on experience developing/optimizing digital tools, automation, and AI/LLM solutions in regulated settings.
- Experience delivering enterprise-wide solutions improving business outcomes.
- Technical change management; create repeatability assessments, job aids, and end-user training materials.
- Mentoring/coaching colleagues or interns.
- Strong collaboration/communication in matrix environments; organizational and project coordination skills.
- Up to 10% travel.
Required Skills:
- Change management; collaboration; eCTD; emerging technologies; liaison work; project leadership; regulatory strategy/submissions/management/reporting; regulatory compliance/documents/experience.
Benefits:
- Eligible for annual bonus and long-term incentive (if applicable). Comprehensive benefits include medical/dental/vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub if a current employee). Application deadline is stated on the posting.