Level-up your Career with Credentials in AI for Regulatory Affairs
This program is designed for both newcomers and experienced professionals in regulatory affairs. Whether you want to upskill by deepening your expertise in your current field or if you want to reskill by pivoting into a new profession altogether, this 6-week, 6-module online course (approximately 24 hours total) explores how artificial intelligence is transforming human therapeutics across the regulatory landscape. Upon successful completion, you’ll earn a Level 2 digital badge from Northeastern University!
AI in Regulatory Sciences
Earners of this badge explored the rapidly evolving intersection of artificial intelligence (AI) and regulatory sciences, with a focus on how AI is transforming the development, approval, and regulatory oversight of human therapeutics. Earners participated in a non-credit course, “AI in Regulatory Sciences,” spanning six modules over six weeks, and engaged with approximately 24 hours of content through guided readings, discussions, and interactive materials. Module topics covered: Introduction to AI and Regulatory Sciences, AI in Drug Discovery, AI in Drug Development, AI in Drug Manufacturing, AI in Regulatory Enabling Functions, and Career Pathways in AI and Regulatory Sciences.
Program Overview
Q: What exactly is this digital badge program?
A: This is a 6-week, 6-module online course (approximately 24 hours total) that explores how artificial intelligence is transforming human therapeutics across the regulatory landscape. Upon successful completion, you’ll earn a Level 2 digital badge from Northeastern University.
Q: What will I learn in each module?
A: The six modules cover:
- Module 1: Core concepts of AI and regulatory sciences
- Module 2: AI in drug discovery (target identification, screening, modeling)
- Module 3: AI in clinical development and trials
- Module 4: AI in manufacturing and supply chain optimization
- Module 5: AI in regulatory operations, pharmacovigilance, and compliance
- Module 6: Career pathways and emerging roles in the AI-regulatory ecosystem
Eligibility & Prerequisites
Q: Do I need a scientific or technical background to take this course?
A: The program is designed for both newcomers and experienced professionals. It is designed for those who want to upskill by deepening your expertise in your current field and for those who want to reskill by pivoting into a new profession altogether.
Q: Who is this program designed for?
A: This badge is ideal for professionals in bio-pharmaceutical, bio-manufacturing, therapeutics, regulatory/compliance, bioethics, policy, and FDA-regulated industries. It’s also suitable for NU students in Regulatory Affairs and Computer Science programs.
Q: Can I take this if I'm not affiliated with Northeastern University?
A: Yes! The program is open to external learners as well as current NU students, faculty, staff, and alumni.
Enrollment & Scheduling
Q: When can I start the program?
A: The program offers rolling/open enrollment, meaning you can start when it’s convenient for you rather than waiting for a specific start date. The program will be available from September 1, 2025 through August 31, 2026.
Q: How do I enroll?
A: Coming soon.
Q: Is this self-paced or do I need to follow a set schedule?
A: The program is designed to be self-paced within the 6-week timeframe, allowing working professionals flexibility in when they complete the modules.
Q: What happens if I can't finish within 6 weeks?
A: This course is intentionally designed to be able to be completed in 6 weeks, with one module per week. You may choose to move faster through the program, or take more time – both are acceptable. However, in order to ensure continuity and flow, we encourage students to complete the modules in quick succession.
Cost & Payment
Q: How much does the program cost?
A: Costs are $1,750 for external learners and $995 for Northeastern-affiliated participants (students, faculty, staff, alumni).
Technical Requirements & Format
Q: What technology do I need to participate?
A: As an online/virtual program, you’ll need reliable internet access and a computer.
Q: Will there be live sessions or is everything recorded?
A: As a self-paced program this badge is based on recorded content.
Q: How will I access course materials?
A: The content is being offered on Canvas, Northeastern’s learning management system. Access details will be provided upon enrollment.
Assessment & Completion
Q: How do I earn the digital badge?
Coming soon.
Q: Can I retake assessments if needed?
A: Since this program is asynchronous and non-congruous, you can start off where you left off or start from the beginning.
Q: How long is the digital badge valid?
A: The badge expires after 5 years.
Q: Will I receive a certificate or just a digital badge?
A: The program awards a digital badge that you can add to your LinkedIn profile as an authenticated demonstration of your expertise in AI for Regulatory Affairs.
Support & Community
Q: Will there be opportunities to network with other participants?
A: Currently, there are no opportunities to network with others taking the course, but we are working on another version which allow for virtual interaction with participants.
Q: Who can I contact if I have technical issues or questions during the course?
A: Jenn Turrentine can address questions you may have during the course. She can be reached at j.turrentine@northeastern.edu.
Career & Professional Development
Q: How will this badge help my career?
A: The badge provides cutting-edge knowledge in the rapidly growing intersection of AI and regulatory sciences. It offers cross-functional skills increasingly sought by biotech, pharma, and regulatory agencies, and explores emerging career pathways in AI-regulatory roles.
Q: Is this badge recognized by employers in the industry?
A: This badge was developed in response to industry demand for training given the growing importance of AI-regulatory skills.
Academic Credit
Q: Can this badge count toward future degree programs?
A: CPS is planning to move the badge into a 4-credit course that could serve as an elective. However, current transfer credit or degree pathway options are not currently available.
Q: Can I use this toward a degree at Northeastern?
A: Future integration into degree programs is being considered, but current degree credit options are not defined.
Q: How will this badge help my career?
A: The badge provides cutting-edge knowledge in the rapidly growing intersection of AI and regulatory sciences. It offers cross-functional skills increasingly sought by biotech, pharma, and regulatory agencies, and explores emerging career pathways in AI-regulatory roles.
Getting Started
Q: How can I learn more or get additional questions answered?
A: For questions not covered here, contact the program administrators Kathi Durning: k.durning@northeastern.edu