Assoc. Dir, Regulatory Affairs-CMC
Merck
August 18, 2026
Remote friendly (North Wales, PA)
United States
Corporate Functions
Responsibilities:
- Drive AI-enabled regulatory authoring capabilities (incl. Module 2/3), develop job aids, and identify generative AI drafting opportunities.
- Monitor emerging AI/digital technologies and assess utility for Regulatory CMC processes.
- Lead cross-functional work for AI authoring, process automation, regulatory intelligence, and digital transformation.
- Establish and embed a CMC digital/AI operating model aligning localized AI efforts with enterprise digital strategies.
- Coordinate with Regulatory CMC Systems/Operations on digital solutions affecting regulatory platforms (e.g., Veeva).
- Serve as primary point of contact for key digital tools/platforms (e.g., ERA App) and support CMC digital tracking/reporting.
- Partner with R&D and Manufacturing to identify shared digital opportunities and ensure data/process handoffs.
- Champion enterprise AI adoption via networks (e.g., AI Pioneers Champions Network), feedback loops, and change management/training.
- Propose/lead/mentor digital project teams, including GRACS CMC summer intern projects.
Education:
- Minimum BS or equivalent in a 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 background.
- Hands-on experience building/optimizing regulated digital tools and modern AI/LLM solutions.
- Enterprise solution delivery experience improving business outcomes.
- Technical change management (repeatability assessments, job aids, end-user training).
- Mentoring/coaching on digital projects/workflows; strong matrix collaboration and communication; project coordination.
- Up to 10% travel.
Required Skills:
- Change management, collaboration, eCTD, emerging technologies, stakeholder partnerships, regulatory CMC/compliance/documents/strategy/submissions/reporting, project leadership, regulatory documents.
Benefits:
- Annual bonus and long-term incentive (if applicable); medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Apply no later than the day before the posted end date (09/1/2026).
- Drive AI-enabled regulatory authoring capabilities (incl. Module 2/3), develop job aids, and identify generative AI drafting opportunities.
- Monitor emerging AI/digital technologies and assess utility for Regulatory CMC processes.
- Lead cross-functional work for AI authoring, process automation, regulatory intelligence, and digital transformation.
- Establish and embed a CMC digital/AI operating model aligning localized AI efforts with enterprise digital strategies.
- Coordinate with Regulatory CMC Systems/Operations on digital solutions affecting regulatory platforms (e.g., Veeva).
- Serve as primary point of contact for key digital tools/platforms (e.g., ERA App) and support CMC digital tracking/reporting.
- Partner with R&D and Manufacturing to identify shared digital opportunities and ensure data/process handoffs.
- Champion enterprise AI adoption via networks (e.g., AI Pioneers Champions Network), feedback loops, and change management/training.
- Propose/lead/mentor digital project teams, including GRACS CMC summer intern projects.
Education:
- Minimum BS or equivalent in a 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 background.
- Hands-on experience building/optimizing regulated digital tools and modern AI/LLM solutions.
- Enterprise solution delivery experience improving business outcomes.
- Technical change management (repeatability assessments, job aids, end-user training).
- Mentoring/coaching on digital projects/workflows; strong matrix collaboration and communication; project coordination.
- Up to 10% travel.
Required Skills:
- Change management, collaboration, eCTD, emerging technologies, stakeholder partnerships, regulatory CMC/compliance/documents/strategy/submissions/reporting, project leadership, regulatory documents.
Benefits:
- Annual bonus and long-term incentive (if applicable); medical/dental/vision, retirement (401(k)), paid holidays/vacation, compassionate and sick days.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub). Apply no later than the day before the posted end date (09/1/2026).