10 AbbVie regulatory affairs leaders
Melodi McNeil, Director, Regulatory Affairs (Global Regulatory Lead) Oncology Early Development, is one of these AbbVie regulatory affairs leaders, whose titles also cover global regulatory strategy, global regulatory leads and US advertising and promotion. A reader can learn how regulatory affairs leaders work at AbbVie from people who have held the role.
Professionals to explore
Amy Ghering
LinkedInExperience: Director of Regulatory Affairs · AbbVie
Amy Ghering has been Director of Regulatory Affairs at AbbVie since March 2022, based in the Greater Chicago Area. Amy Ghering was Director, Regulatory Affairs at Takeda from 2020 to 2022, Director of Regulatory Affairs at Xeris Pharmaceuticals, Inc. from 2018 to 2020, Associate Director Regulatory Affairs at Abbott from 2015 to 2017 and Scientific Reviewer at FDA from 2012 to 2015.
Caroline E Kim, PharmD
LinkedInExperience: Director, Regulatory Affairs, Oncology · AbbVie
Caroline E Kim has been Director, Regulatory Affairs, Oncology at AbbVie since February 2025 and was Associate Director, Regulatory Affairs, Oncology there from 2022 to 2025, based in New York, New York. Caroline E Kim was Senior Manager Regulatory Affairs at Regeneron from 2020 to 2022 and Manager, Regulatory Affairs at Acorda Therapeutics, Inc. from 2018 to 2019.
Erik Stanek
LinkedInExperience: Director, Regulatory Affairs, US Advertising and Promotion, Digital and Corporate Communications · AbbVie
Erik Stanek has been Director, Regulatory Affairs, US Advertising and Promotion, Digital and Corporate Communications at AbbVie since May 2023 and was Associate Director, Regulatory Affairs, Advertising and Promotion there from 2018 to 2023. Erik Stanek was Senior Regulatory Affairs Manager, Labeling, Advertising and Promotion at Baxter International Inc. from 2007 to 2018.
Guang Yang
LinkedInExperience: Director, Regulatory Affairs, Global Regulatory Strategy · AbbVie
Guang Yang has been Director, Regulatory Affairs, Global Regulatory Strategy at AbbVie Inc. since May 2024, based in North Chicago, Illinois. At AbbVie Inc., Guang Yang was Associate Director, Regulatory Affairs, Global Regulatory Strategy from 2019 to 2024 and Associate Director, Regulatory Affairs, Japan, Asia Pacific Region from 2015 to 2019.
Harshal Gupte M.S.(Pharm.), RAC
LinkedInExperience: Director, Global Regulatory Lead (GRL) · AbbVie
Harshal Gupte has been Director, Global Regulatory Lead (GRL) at AbbVie since May 2022 and was Associate Director, Regulatory Affairs there from 2020 to 2022, based in North Chicago, Illinois. Harshal Gupte was Manager, Global Regulatory Affairs, GRL, Sterile Injectables at Pfizer from 2016 to 2020 and Sr. Regulatory Affairs Specialist, Global Regulatory Affairs at Hospira from 2013 to 2015.
Israel Owolabi, PharmD
LinkedInExperience: Director, Regulatory Affairs US Advertising and Promotion · AbbVie
Israel Owolabi has been Director, Regulatory Affairs US Advertising and Promotion at AbbVie since March 2022, based in North Chicago, Illinois. At AbbVie, Israel Owolabi was Associate Director, Regulatory Affairs US Advertising and Promotion from 2019 to 2022, Senior Manager, Regulatory Affairs US Advertising and Promotion from 2018 to 2019 and Manager, Regulatory Affairs US Advertising and Promotion from 2016 to 2018.
Julie Astanov
LinkedInExperience: Director Global Regulatory Strategy · AbbVie
Julie Astanov has been Director Global Regulatory Strategy at AbbVie since June 2025, based in the San Francisco Bay Area. At AbbVie, Julie Astanov was Associate Director, Global Regulatory Strategy from 2021 to 2025 and Senior Manager, Regulatory Affairs from 2017 to 2019, and was Associate Director, Global Regulatory Affairs at Rakuten Medical from 2019 to 2021.
Melodi McNeil
LinkedInExperience: Director, Regulatory Affairs (Global Regulatory Lead) Oncology Early Development · AbbVie
Melodi McNeil has been Director, Regulatory Affairs (Global Regulatory Lead) Oncology Early Development at AbbVie since March 2025, based in Silver Spring, Maryland. Melodi McNeil was Director, Regulatory Policy and Intelligence at AbbVie from 2013 to 2025 and at Abbott from 2006 to 2012, and was Special Assistant to the Director, Office of Pharmacoepidemiology and Statistical Science at FDA from 2002 to 2006.
Pallavi Sharma
LinkedInExperience: Director of Regulatory Affairs, Early Oncology Development · AbbVie
Pallavi Sharma has been Director of Regulatory Affairs, Early Oncology Development at AbbVie since July 2022, based in San Mateo, California. Pallavi Sharma was Associate Director of Regulatory Affairs at Nektar Therapeutics from 2020 to 2022 and Regulatory Program Manager at Genentech from 2015 to 2019, and the profile describes work across clinical and CMC regulatory.
Viraj B. Gandhi
LinkedInExperience: Director, Global Regulatory Lead · AbbVie
Viraj B. Gandhi has been Director, Global Regulatory Lead at AbbVie since May 2023, based in Buffalo Grove, Illinois. At AbbVie, Viraj B. Gandhi was Associate Director, Regulatory Affairs from 2018 to 2023 and Senior Manager, Regulatory Affairs from 2014 to 2018, and the profile describes leading global regulatory strategy across multiple therapeutic areas.
Choose the right perspective
Match the scope named in a person's title, such as global regulatory strategy, a therapeutic area or US advertising and promotion, to the question you need answered. Weigh how close the scope of each person's role is to the decision you face.
Questions to take into the conversation
- 01What did you focus on first when you took on your regulatory affairs role at AbbVie?
- 02What decision in your AbbVie regulatory affairs role would you make differently today, and why?
- 03What has your own work at AbbVie taught you about building a regulatory affairs team?
Reaching AbbVie 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.
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