A: Since human medicines are regulated by health authorities and regulatory agencies such as the FDA, this course will focus on regulatory sciences and AI. You will learn how various regulatory agencies regulate the AI-enabled ecosystem for human therapeutics, encompassing systems, platforms, processes, and products. This is a 6-week, 7-module online course (approximately 24 hours total) that explores how artificial intelligence is transforming human therapeutics across the regulated landscape. Upon successful completion, you will earn a Level 1 digital badge. If you opt to do a capstone project, a Level 2 digital badge will be awarded from the College of Professional Studies at Northeastern University.

The course is structured into 7 modules with focus on Regulatory Sciences & AI

1. Introduction to AI in Regulatory Sciences

2. Role of AI in drug discovery

3. Role of AI in drug development

4. Role of AI in drug manufacturing

5. AI in enabling regulatory functions (e.g., reg ops, PV, lifecycle management, compliance & reg intel)

6. Medical Devices and AI

7. Preparing for roles in AI-enabled ecosystem for biotherapeutics and Regulatory Sciences

Total Time: ~24 hrs (~4 hrs/week)

A: This program is designed for both newcomers and experienced professionals in regulatory affairs. So, who is this course for? You. If you already work in regulatory affairs, you upskill; you go deeper. If you are coming from an adjacent field such bioinformatics, clinical research or drug discover, you reskill; you cross-over. And if you are coming from outside biopharma entirely, you offskill; you start here

A: This badge is ideal for professionals who already are in bio-pharmaceutical, bio-manufacturing, therapeutics, regulatory/compliance, bioethics, policy, and FDA-regulated industries. It is also suitable for NU students in who want to learn about fundamentals of regulatory sciences and how AI is being used and regulated. It is an excellent course for those who are new to biopharma as this course goes into detail from how AI is applied in drug discovery, development, manufacturing, enabling regulatory functions and medical devices. Drug regulators would also benefit from a comprehensive overview of how AI-enabled ecosystem is being regulated and the evolving regulations and guidelines across various jurisdictions.

A: Yes! The program is open to external learners as well as current NU students, faculty, staff, and alumni.

A: The program offers rolling/open enrollment, meaning you can start when it is convenient for you rather than waiting for a specific start date. The program will be available from Aug 31, 2026 through August 30, 2027.

A: Use the link below to enroll. https://cps.skillstack.northeastern.edu/courses/crw0017-ai-in-regulatory-sciences2

A: This on-line program is designed to be self-paced which will take about 6-weeks, allowing working professionals and students flexibility in when they complete the modules and the course.

A: This course is intentionally designed to be able to be completed in about 6 weeks, with about 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.

A: Costs are $1,750 for external learners and $995 for Northeastern-affiliated participants (students, faculty, staff, alumni). For teams of more than 5 seats from the same institution, or for an institutional license for more than 25, please contact us at [email protected]. If you are staff at health authorities and regulatory agencies, please write to us for special rates.

A: As an online/virtual program, you will need reliable internet access and a computer.

A: As a self-paced program, this course is based on recorded content. Throughout the course, you will be prompted to check your knowledge through questions and are encouraged to contribute to a reflection log.

A: The content is being offered on Canvas, Northeastern’s learning management system. Access details will be provided upon enrollment.

You have option to get a Level 1 or Level 2 badge. Upon completion of the course, you will automatically get the Level 1 badge. If you do the optional capstone project, you will be awarded a Level 2 badge.

A: Since this program is asynchronous and non-congruous, you can start off where you left off or start from the beginning.

A: The badge expires after 5 years.

A. The program awards a digital badge that you can add to your LinkedIn profile as an authenticated demonstration of your expertise in the field of Regulatory Sciences and AI.

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.

A: Jenn Turrentine can address questions you may have during the course. She can be reached at [email protected].

A: That depends on where you are starting, and the course is built for three different starting points.

If you already work in regulatory affairs, pharmacovigilance, or drug development, this is an upskill. You will build literacy in how AI systems actually work, understand the regulatory frameworks now emerging around them, and learn how to bring AI tools into your own decision-making and workflows. It prepares you to lead the conversation in your organization rather than react to it. Where there are no regulations, this course teaches you to think like a regulator.

If you are coming from an adjacent field such as data science, bioinformatics, or public policy, this is a reskill. You already have technical or analytical depth. What you need is the regulatory context that turns it into a career in therapeutics: how products get approved, who decides, and where AI is changing that.

And if you are coming from outside biopharma entirely, this is an offskill. It is a deliberate move into a new industry at a moment when the entry points are wider than usual, because the intersection of AI and regulation is new enough that almost everyone in it arrived from somewhere else.

A: This badge was developed in response to industry demand for training given the growing importance of AI-regulatory skills. You can share this badge of LinkedIn and include this on your resume.

A: Not yet. However, College of Professional Studies (CPS) is evaluating 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.

A: Future integration into degree programs is being considered, but current degree credit options are not defined.

A: For questions not covered here, contact the program administrators Kathi Durning: [email protected] or write to [email protected].