Regulatory affairs is expanding rapidly, and both students and working professionals are looking for practical ways to enter this field. This session brings together industry experts to demystify the regulatory landscape, highlight the diverse areas you can work in, and show how AI is already changing regulatory workflows. We will discuss real-world case studies from drugs, biologics, and medical devices, explain how regulatory fits within the product lifecycle, and outline the skills that help new professionals stand out, such as scientific writing, documentation, cross-functional communication, and responsible use of digital tools.
Attendees will also gain a clear view of the regulatory career ladder, pathways for transitioning from non-traditional backgrounds, and practical strategies to upskill for the evolving market.
Registration Fees & Deadlines
Member $30 | Nonmember $50 | Student Member $0
Learning Objectives
Understand the scope of regulatory affairs across drugs, biologics, medical devices, and clinical research, including the core functions, lifecycle responsibilities, common misconceptions, and the diverse entry pathways available through both traditional and non-traditional backgrounds.
Gain insight into the role of AI and emerging technologies in regulatory work, including how tools are used for guidance summarization, document drafting, and regulatory intelligence, while recognizing the essential limitations that still require human judgment, oversight, and ethical responsibility.
Explore high-value capstone and research project ideas recommended by industry panelists that reflect current market needs and help students and early-career professionals build strong regulatory foundations and career readiness.
Who Should Attend?
This event is ideal for professionals at all levels of experience in regulatory affairs, quality management, compliance, and related fields.
Agenda
5:15 pm -5:45 pm – Registration and networking
5:45pm - 6:00pm Welcome and introduce RAPS SF Chapter & SJSU
6:00 – 7:15 – Speaker Panel
7:15-8:15 - Networking
Speakers
Maurizio Franzini
Senior Director, Gilead Sciences
Maurizio Franzini is a Senior Director at Gilead Sciences (Foster City, CA), leading Regulatory Affairs, CMC work for small molecule programs. He is a people leader and supports CMC regulatory strategy and submissions across development and lifecycle activities.
Prapaporn Kulphaisal
Manager, CMC Regulatory Affairs, Gilead
Prapaporn Kulphaisal is a Manager, CMC Regulatory Affairs at Gilead Sciences, supporting CMC regulatory strategy and submissions across product development and lifecycle activities.
Deep Shah
CMC Regulatory Affairs and Global Regulatory Leader, Sana Biotechnology, Inc.
Deep Shah is a Senior Director, CMC Regulatory Affairs and Global Regulatory Leader at Sana Biotechnology, Inc. (South San Francisco, CA). He oversees both clinical and CMC regulatory responsibilities.
Angela (Bencomo) Frederickson
Founder and Principal RAQA Consultant, Sparq Compliance
Angela (Bencomo) Frederickson is the Founder and Principal RAQA Consultant at Sparq Compliance (California, U.S.). She supports clients with regulatory affairs and quality (RAQA) strategy and execution.
Nestor Vazquez
Regulatory Affairs Specialist, Intuitive.
Nikita Sehgal
Clinical Research Coordinator (CRC), Stanford University,
RAPS volunteer, and SJSU alumna (Class of 2025).
Surina Gulati
Quality Systems Engineering Lead, iRhythm Technologies
San Francisco Bay Area Chapter Chair for Professional Development
Location
San Jose State University
Interdisciplinary Science Building (ISB) Room 130
One Washington Square
San Jose, CA 95192-0126, USA
Cancellations and Refunds
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
support@raps.org.