Associate Director, Regulatory Affairs – CMC

Jobtailor; New Jersey; On-site; USD 130,000 - 170,000; Full time

Job summary

Jobtailor in New Jersey seeks a strategic Regulatory CMC AI Lead to advance AI-enabled regulatory authoring capabilities, including Module 2/3 innovations, and draft practical job aids. You will track AI/ML developments, coordinate cross-functional teams across R&D, Manufacturing, and Regulatory, and partner with Regulatory CMC Systems to deploy digital tools such as Veeva ERA App.

This role emphasizes change management, mentoring, and data-driven process improvements across enterprise digital

Qualifications

• BS or equivalent degree in science/engineering (chemistry/biology/pharma/compsci acceptable).
• At least 5 years in pharmaceutical/biotech with Regulatory CMC/Regulatory Affairs background.
• Hands-on with digital tools, automation and AI/LLM in regulated settings.
• Experience delivering enterprise-wide digital solutions and improving outcomes.
• Experience with technical change management, including training materials.
• Mentoring/coaching colleagues on digital projects and workflows.
• Strong collaboration and matrix-work across research, manufacturing and IT.

Responsibilities

• 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 AI/ML advancements and assess utility for Regulatory CMC processes.
• Lead cross-functional AI authoring, automation, regulatory intelligence and digital transformation.
• Support the CMC digital operating model and align localized AI efforts with enterprise strategy.
• Partner with Regulatory CMC Systems/Operations on digital solutions (e.g., Veeva).
• Serve as primary Regulatory CMC contact for digital tools and ERA App.
• Support CMC digital priority tracking and progress reporting.
• Identify shared digital opportunities across R&D, Manufacturing, Regulatory.
• Ensure smooth data and process handoffs between manufacturing, research and regulatory.
• Champion enterprise-wide AI adoption via champion networks and feedback loops.
• Drive change management and training activities.
• Lead and mentor digital project teams, including GRACS CMC intern projects.
• Foster collaboration across the broader AI/Digital Enablement community.

Skills

Change Management

Collaboration

Communication

Mentoring

Project Leadership

Regulatory Affairs

Regulatory CMC

Regulatory Compliance

Regulatory Submissions

Stakeholder Partnerships

Multitasking

Education

BS or equivalent degree in science/engineering

Tools

Veeva

ERA App

AI Technologies

Machine Learning

Digital Solutions

Job description

• 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

• 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.

Core Competencies

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.

Hard Skills

• Regulatory Affairs Management


• Regulatory Compliance


• Regulatory Strategy Development


• Regulatory Submissions


• Electronic Common Technical Document (eCTD)


• Automation


• AI/LLM Solutions


• Technical Change Management


• Manufacturing Processes


• Data Analytics

Soft Skills

• Collaboration


• Communication


• Organizational Skills


• Interpersonal Relationships


• Mentoring

Industry Keywords

• Pharmaceutical


• Biotech


• Regulatory Experience


• Stakeholder Partnerships


• Project Coordination

Tools & Technologies

• Veeva


• ERA App


• Digital Solutions


• AI Technologies


• Machine Learning