Associate Director, Regulatory Affairs – CMC

MSD

Associate Director advancing AI-enabled authoring and digital Regulatory CMC solutions at global healthcare company. Leading cross-functional innovation, adoption, reporting, and training across research and manufacturing.

Posted 8/17/2026full-timeRahway • New Jersey, Pennsylvania • 🇺🇸 United StatesMid-LevelSenior💰 $142,400 - $224,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Regulatory CMC processes and AI-enabled digital solutions, with a strong focus on change management, collaboration, and project leadership. Proven ability to drive innovation and optimize regulatory authoring capabilities in a pharmaceutical or biotech environment.

Highest-signal resume keywords

Regulatory CMCChange ManagementDigital Tools DevelopmentProject LeadershipCollaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Affairs ManagementRegulatory ComplianceRegulatory Strategy DevelopmentRegulatory SubmissionsElectronic Common Technical Document (eCTD)AutomationAI/LLM SolutionsTechnical Change ManagementManufacturing ProcessesData Analytics

Soft Skills

CollaborationCommunicationOrganizational SkillsInterpersonal RelationshipsMentoring

Tools & Technologies

VeevaERA AppDigital SolutionsAI TechnologiesMachine Learning

Industry Keywords

PharmaceuticalBiotechRegulatory ExperienceStakeholder PartnershipsProject Coordination

About the role

Key responsibilities & impact

Drive advancement of AI-enabled regulatory authoring capabilities, including Module 2/3 authoring innovations.
Draft practical job aids and identify generative AI drafting opportunities.
Track technological advancements in AI, machine learning, and digital tools and assess their utility for Regulatory CMC processes.
Lead and coordinate cross-functional AI authoring, process automation, regulatory intelligence, and digital transformation activities.
Support the CMC digital/AI operating model and align localized AI efforts with enterprise digital strategies.
Partner with Regulatory CMC Systems/Operations on digital solutions affecting regulatory platforms such as Veeva.
Serve as the primary Regulatory CMC contact for selected digital tools and platforms, including the ERA App.
Support CMC digital priority tracking and progress reporting.
Identify shared digital opportunities and co-develop solutions across Research & Development, Manufacturing, and Regulatory.
Ensure smooth data and process handoffs between manufacturing, research, and regulatory.
Champion enterprise-wide AI adoption through champion networks and feedback loops.
Drive change management and training activities.
Lead and mentor digital project teams, including GRACS CMC summer intern projects.
Foster collaboration across the broader AI/Digital Enablement community.

Requirements

What you’ll need

Minimum BS or equivalent scientific, technical, or regulatory degree; chemistry, biology, pharmacy, computer science, or data analytics preferred.
Minimum five 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 for end-users.
Experience mentoring and coaching colleagues or interns on digital projects and technical workflows.
Strong collaboration and communication skills and ability to work effectively in a matrix environment across research, manufacturing, and IT.
Strong organizational and project coordination skills with ability to manage multiple overlapping initiatives.
Up to 10% travel.
Required skills: Change Management, Collaboration, Electronic Common Technical Document (eCTD), Emerging Technologies, Interpersonal Relationships, Liaison Work, Manufacturing Processes, Multitasking, Project Leadership, Regulatory Affairs Management, Regulatory CMC, Regulatory Compliance, Regulatory Documents, Regulatory Experience, Regulatory Management, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions, Stakeholder Partnerships.
No visa sponsorship.

Benefits

Comp & perks

Annual bonus eligibility
Long-term incentive eligibility, if applicable
Medical healthcare insurance for employee and family
Dental healthcare insurance for employee and family
Vision healthcare insurance for employee and family
Other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate days
Sick days
Hybrid work arrangement