10 Genentech regulatory affairs leaders
Regulatory Senior Group Director, Group Director Regulatory Affairs and Director Regulatory Affairs are among the roles held by these ten Genentech regulatory affairs leaders. A reader can learn how regulatory affairs leaders work at Genentech from people who have held the role.
Professionals to explore
Cynthia Nguyen
LinkedInExperience: Senior Director Regulatory Affairs · Genentech
Cynthia Nguyen has been Senior Director Regulatory Affairs at Genentech since June 2025, based in Philadelphia, Pennsylvania. Cynthia Nguyen was Senior Director Regulatory Affairs at Spark Therapeutics, Inc. from 2024 to 2025 and Director, Regulatory Affairs Strategy Leader there from 2022 to 2024, and was Program Director- Regulatory Oncology at Genentech from 2019 to 2021.
Isa Samuels
LinkedInExperience: Senior Director, Global Regulatory Affairs · Genentech
Isa Samuels has been Senior Director, Global Regulatory Affairs at Genentech since 2015, based in Brisbane, California. Isa Samuels was Director, Global Regulatory Affairs at InterMune from 2004 to 2015, a Scientist at Bayer from 2001 to 2004 and a Research Specialist at Chiron Corporation from 1998 to 2001.
Jaya Nayini
LinkedInExperience: Group Director, Commercial Regulatory Affairs · Genentech
Jaya Nayini has been Group Director, Commercial Regulatory Affairs at Genentech since October 2016, based in the San Francisco Bay Area. Jaya Nayini was Director Regulatory Affairs, Advertising & promotion at Mallinckrodt Pharmaceuticals from 2014 to 2016 and Director, Regulatory Affairs Advertising & Promotion at Abbott/Abbvie from 2011 to 2014.
Nishchay Gupta
LinkedInExperience: Regulatory Group Director · Genentech
Nishchay Gupta has been Regulatory Group Director at Genentech since November 2024, based in Daly City, California, and the profile headline names medical devices and combination products. At Genentech, Nishchay Gupta was Sr. Regulatory Program Director from 2023 to 2024, Regulatory Program Director from 2020 to 2023 and Associate Regulatory Program Director from 2018 to 2020.
Nitzan Sternheim, PhD
LinkedInExperience: Senior Group Director, Regulatory Affairs · Genentech
Nitzan Sternheim has been Senior Group Director, Regulatory Affairs at Genentech since September 2023, based in the San Francisco Bay Area. At Genentech, Nitzan Sternheim was Group Director, Regulatory Affairs from 2017 to 2023, Senior Program Director, Regulatory Affairs from 2017 to 2021 and Program Director, Regulatory Affairs from 2015 to 2017.
Prateek Haldar
LinkedInExperience: Group Director, Regulatory Affairs · Genentech
Prateek Haldar has been Group Director, Regulatory Affairs at Genentech since March 2019, based in Berkeley, California. At Genentech, Prateek Haldar was Program Director Regulatory Affairs from 2015 to 2019 and Regulatory Documentation Senior Manager from 2014 to 2015, and was Regulatory Documentation Manager at Roche from 2011 to 2012.
Robyn Harrington
LinkedInExperience: Regulatory Senior Group Director · Genentech
Robyn Harrington has been Regulatory Senior Group Director at Genentech since May 2020, based in San Francisco, California. At Genentech, Robyn Harrington was Associate Group Director - Regulatory from 2018 to 2020, Senior Regulatory Program Director from 2017 to 2018 and Regulatory Program Director from 2012 to 2017.
Shelly Allen York
LinkedInExperience: Director Regulatory Affairs · Genentech
Shelly Allen York has been Director Regulatory Affairs at Genentech since November 2022, based in San Francisco, California. Shelly Allen York was Associate Director Regulatory Affairs at Genentech from 2019 to 2022 and Manager Regulatory Affairs at Five Prime Therapeutics, Inc. from 2018 to 2019.
Tim Burkoth
LinkedInExperience: Group Director Regulatory Affairs · Genentech
Tim Burkoth has been Group Director Regulatory Affairs at Genentech since March 2019, based in Oakland, California, and the profile headline gives the same title. The listing shows no other roles on the profile, so check the full profile for the rest of the background.
Zahedeh Hatamkhany
LinkedInExperience: Senior Director, Regulatory - Combination Products, Devices & Digital Health · Genentech/Roche
Zahedeh Hatamkhany has been Senior Director, Regulatory - Combination Products, Devices & Digital Health at Genentech/Roche since August 2019, based in the San Francisco Bay Area. Zahedeh Hatamkhany was Director of Regulatory Affairs at Dermira, Inc. from 2018 to 2019 and Associate Director, Regulatory Affairs, CMC & Combination Products at Proteus Digital Health, Inc from 2010 to 2018.
Choose the right perspective
Match the area named in a person's title, such as global regulatory affairs, commercial regulatory affairs or combination products and devices, to the question you need answered. Consider whether a long career inside Genentech or time at other drug developers gives the view your decision needs.
Questions to take into the conversation
- 01What did you focus on first when you took on your regulatory affairs role at Genentech?
- 02Which regulatory affairs decision at Genentech would you make differently today, and why?
- 03What has your own work taught you about leading a regulatory group at Genentech?
Reaching Genentech regulatory affairs leaders
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About this directory
This is a professional research starting point based on business profile data retrieved on . Titles and companies reflect that source snapshot; roles marked former had ended by then. Check the linked profiles for current details. Inclusion does not imply Instant Expert membership or availability.