Assoc. Dir, Regulatory Affairs-CMC

Merck • North Wales, PA

2d • $142,400 - $224,100 • Hybrid

About The Position

The Associate Director, Regulatory CMC Digital Innovation is a key execution and enablement-focused role reporting to the Executive Director of Regulatory CMC Digital Innovation. The role will focus on developing digital and AI (Artificial Intelligence) innovations and solutions across all aspects of Regulatory CMC workflows. This individual will serve as a subject matter expert (SME) to help Regulatory CMC teams develop, adopt, implement, and maximize digital and AI tools to drive productivity and operational excellence. Additionally, this role will link Regulatory CMC initiatives to GRACS-wide projects and broader Enterprise Digital Initiatives and partnering closely with counterparts (in our Research & Development Division and our Manufacturing Division) to develop and implement integrated solutions.

Requirements

• Minimum BS or equivalent Scientific, Technical, or Regulatory degree (focus on chemistry, biology, pharmacy, computer science, or data analytics preferred).
• Minimum of five (5) years of experience in the pharmaceutical or biotech industry, with a 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, with a capability to design 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, with a proven ability to work effectively in a matrix environment across various functional units (such as research, manufacturing, and IT).
• Strong organizational and project coordination skills, with the ability to manage multiple overlapping initiatives simultaneously.

Nice To Haves

• Current Employees apply HERE
• Current Contingent Workers apply HERE

Responsibilities

• Drive the advancement of AI-enabled regulatory authoring capabilities (including Module 2/3 authoring innovations), drafting practical job aids, and continuously identifying novel generative AI drafting opportunities.
• Keep abreast of rapid technological advancements (the latest AI, machine learning, digital tools, etc.) and assessing their utility for Regulatory CMC processes.
• Lead and coordinate cross-functional activities relating to development of AI authoring, process automation, regulatory intelligence, and digital transformation initiatives.
• Partner in establishing, communicating, and embedding the CMC digital/AI operating model to connect, align, and scale localized AI efforts with broader enterprise digital strategies.
• Partner with the Regulatory CMC Systems/Operations group regarding the development of digital solutions impacting our regulatory platforms (e.g., Veeva) as needed.
• Serve as the primary Regulatory CMC point of contact for selected key digital tools and platforms (such as the ERA App), and support CMC digital priority tracking and progress reporting.
• Work collaboratively across our Divisions to identify shared digital opportunities, co-develop cross-functional solutions, and ensure smooth data and process handoffs between manufacturing, research, and regulatory.
• Actively champion enterprise-wide AI adoption by participating in champion networks (e.g., AI Pioneers Champions Network), coordinating feedback loops, and driving change management and training activities.
• Propose, lead, and mentor digital project teams—including guiding GRACS CMC summer intern projects focused on AI-enabled authoring and process improvement—while fostering collaboration across the broader AI/Digital Enablement community.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Manager