Associate Director, Regulatory Affairs – CMC

MSD

. Develop digital and AI innovations and solutions across Regulatory CMC workflows .

Posted 10/2/2026full-timeUnited StatesMid-LevelSenior💰 $142,400 - $224,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory CMC and AI innovations, with a strong focus on developing and implementing digital tools and automation solutions in a regulated environment. Proven ability to lead cross-functional teams, mentor colleagues, and drive enterprise-wide change management initiatives.

Highest-signal resume keywords

Regulatory CMC ExpertiseAI/LLM Solutions DevelopmentDigital Tool ImplementationChange Management ExperienceProject Leadership

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsDigital TransformationProcess AutomationTechnical Change ManagementProject CoordinationEmerging Technologies AssessmentRegulatory SubmissionsRegulatory ComplianceJob Aid DevelopmentMentoring and Coaching

Soft Skills

Organizational SkillsCollaborationCommunication

Tools & Technologies

VeevaERA AppECTD

Industry Keywords

Pharmaceutical IndustryBiotech IndustryRegulatory ManagementRegulatory Strategy DevelopmentStakeholder Partnerships

About the role

Key responsibilities & impact

Develop digital and AI innovations and solutions across Regulatory CMC workflows
Serve as a Regulatory CMC digital and AI subject matter expert
Drive AI-enabled regulatory authoring capabilities, including Module 2/3 authoring innovations
Draft practical job aids and identify generative AI drafting opportunities
Assess emerging AI, machine learning, and digital technologies for Regulatory CMC processes
Lead cross-functional activities for AI authoring, process automation, regulatory intelligence, and digital transformation
Support the CMC digital/AI operating model and align localized AI efforts with enterprise digital strategies
Partner with the Regulatory CMC Systems/Operations group on digital solutions affecting regulatory platforms such as Veeva
Own selected key digital tools and platforms, including the ERA App
Track CMC digital priorities and report progress
Collaborate across research, manufacturing, and regulatory divisions to identify opportunities and develop integrated solutions
Champion enterprise-wide AI adoption through champion networks, feedback loops, change management, and training
Lead and mentor digital project teams, including GRACS CMC summer intern projects
Report to the Executive Director of Regulatory CMC Digital Innovation
Travel up to 10%

Requirements

What you’ll need

Minimum BS or equivalent scientific, technical, or regulatory degree; chemistry, biology, pharmacy, computer science, or data analytics preferred
Minimum of five (5) years of experience in the pharmaceutical or biotech industry
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
Demonstrated experience delivering enterprise-wide solutions that improve business outcomes
Experience in technical change management, including designing repeatability assessments, job aids, and training materials
Experience mentoring and coaching colleagues or interns on digital projects and technical workflows
Ability to work effectively in a matrix environment across research, manufacturing, and IT
Strong organizational and project coordination skills; ability to manage multiple overlapping initiatives
Knowledge of Change Management, Electronic Common Technical Document (eCTD), Emerging Technologies, Manufacturing Processes, Project Leadership, Regulatory Affairs Management, Regulatory CMC, Regulatory Compliance, Regulatory Documents, Regulatory Experience, Regulatory Management, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions, and Stakeholder Partnerships
Up to 10% travel
US and Puerto Rico residents only
Visa sponsorship: No

Benefits

Comp & perks

Annual bonus and long-term incentive, if applicable
Medical, dental, and vision healthcare
Other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Hybrid work arrangement
Mentorship and career development opportunities
Relocation: No relocation