Overview In this role you will drive digital and AI-enabled initiatives across Regulatory CMC to improve efficiency and compliance. You will collaborate with cross-functional teams to implement innovative tools, operate within a digital operating model, and champion enterprise-wide AI adoption. You will partner with Manufacturing and R&D to deliver integrated, scalable solutions such as AI-enabled authoring and automated processes. This is an opportunity to shape the future of regulatory digital workflows within a global pharma leader.
Compensation / Benefits- medical, dental, vision
- retirement benefits including 401(k)
- paid holidays
- vacation
- compassionate and sick days
- annual bonus and long-term incentive (eligible)
Responsibilities- Advance AI-enabled regulatory authoring, including Module 2/3 innovations and practical job aids
- Monitor and evaluate emerging AI and digital technologies for Regulatory CMC use
- Lead cross-functional activities for AI authoring, automation, regulatory intelligence, and digital transformation
- Support the Digital Operating Model to connect local AI efforts with enterprise strategies
- Collaborate with Regulatory CMC Systems/Operations on digital solutions (e.g., Veeva)
- Act as primary contact for key digital tools/platforms (e.g., ERA App) and support priority tracking
- Foster collaboration across Divisions (R&D, Manufacturing) to identify shared digital opportunities
- Advocate AI adoption through networks, feedback loops, and training initiatives
- Lead and mentor digital project teams, including internship projects in AI-enabled authoring
- Educate and disseminate digital practices across GRACS CMC and broader AI community
Key requirements- BS or equivalent scientific, technical, or regulatory degree
- minimum 5 years in pharmaceutical/biotech with Regulatory CMC or related operations
- hands-on experience developing/implementing digital tools, automation, and AI/LLM solutions in regulated settings
- proven track record delivering enterprise-wide solutions that improve outcomes
- experience with change management, end-user training, and job aids
- ability to mentor colleagues or interns on digital projects
- strong collaboration/communication in a matrix organization across research, manufacturing, IT
- excellent organizational and project coordination skills; ability to manage multiple initiatives
- up to 10% travel
- collaboration
- communication
- change management
- AI/LLM solutions
- Regulatory CMC knowledge
- digital tools and automation
