10 heads of regulatory affairs
Head of Regulatory Affairs, often paired with a vice president or executive director title, is the current role held by these heads of regulatory affairs at biotechnology and pharmaceutical companies. A reader can learn how heads of regulatory affairs approach their work from people who have held the role.
Professionals to explore
Alissa Minkoff
LinkedInExperience: Executive Director, Head of Regulatory Affairs · Marea Therapeutics
Alissa Minkoff has been Executive Director, Head of Regulatory Affairs at Marea Therapeutics since August 2025, based in South San Francisco. Alissa Minkoff was Executive Director, Head of Regulatory Affairs at Third Harmonic Bio from 2024 to 2025 and Senior Director, Head of Regulatory Affairs at Ventus Therapeutics from 2023 to 2024.
Chayla Freeman, MS, JD
LinkedInExperience: Executive Director, Head of Regulatory Affairs · Alkeus Pharmaceuticals, Inc.
Chayla Freeman has been Executive Director, Head of Regulatory Affairs at Alkeus Pharmaceuticals, Inc. since May 2024, based in Boston. Chayla Freeman was Director of Regulatory Affairs at Vertex Pharmaceuticals from 2019 to 2024 and Global Regulatory Affairs Lead- Neuroscience at Shire from 2017 to 2019.
Elvis Osei Tutu, Pharm.D, RAC
LinkedInExperience: Vice President, Head of Regulatory Affairs · Crescent Biopharma
Elvis Osei Tutu has been Vice President, Head of Regulatory Affairs at Crescent Biopharma since September 2025, based in Boston. Elvis Osei Tutu was Vice President, Head of Regulatory Affairs at Fusion Pharmaceuticals from 2023 to 2025 and at Magenta Therapeutics from 2022 to 2023.
Jodi Schinski
LinkedInExperience: Head of Regulatory Affairs & Quality Assurance · Elion Therapeutics
Jodi Schinski has been Head of Regulatory Affairs & Quality Assurance at Elion Therapeutics since December 2025, based in Greater Philadelphia. Jodi Schinski was Senior Director, Regulatory Affairs at Cidara Therapeutics from 2023 to 2025 and Director, Regulatory Affairs, CMC at Merck from 2018 to 2022.
Katrin Rupalla
LinkedInExperience: Head of Global Regulatory Affairs, Johnson and Johnson Innovative Medicines · Johnson & Johnson Innovative Medicine
Katrin Rupalla has been Head of Global Regulatory Affairs, Johnson and Johnson Innovative Medicines at Johnson & Johnson Innovative Medicine since June 2023, based in Titusville, New Jersey. Katrin Rupalla was CEO and Founder at Ymmunobio AG from 2021 to 2023 and describes global regulatory, research and leadership positions at pharmaceutical and biotech companies.
Khan Maola, PhD
LinkedInExperience: VP/Head of Regulatory Affairs · Tethra Biosciences
Khan Maola has been VP/Head of Regulatory Affairs at Tethra Biosciences since October 2025 and also lists Head of Regulatory Affairs at Cyclacel Pharmaceuticals, Inc. since 2020, based in Winchester, Massachusetts. Khan Maola was Head of Regulatory Affairs at ArQule from 2019 to 2020.
Michael Ladd PharmD, RPh
LinkedInExperience: VP, Head of Global Regulatory Affairs · Solstice Oncology
Michael Ladd has been VP, Head of Global Regulatory Affairs at Solstice Oncology since March 2026, based in the Miami-Fort Lauderdale Area. Michael Ladd was VP Regulatory Science at Trevi Therapeutics, Inc. from 2025 to 2026 and VP, Head of Regulatory Affairs at Mural Oncology from 2024 to 2025.
Ramon Polo
LinkedInExperience: Senior Vice President, Head Global Regulatory Affairs · Aligos Therapeutics
Ramon Polo has been Senior Vice President, Head Global Regulatory Affairs at Aligos Therapeutics since July 2025, based in Basking Ridge, New Jersey. Ramon Polo was Senior Vice President, Head of Global Regulatory Affairs at Shionogi & Co., Ltd from 2024 to 2025 and Vice-president Head of ID, Vaccines and GPH Global Regulatory Affairs at Johnson & Johnson Innovative Medicine from 2015 to 2024.
Rob Kalesnik-Orszulak
LinkedInExperience: Head of Regulatory Affairs · Retro Biosciences
Rob Kalesnik-Orszulak has been Head of Regulatory Affairs at Retro Biosciences since July 2025, based in San Francisco. Rob Kalesnik-Orszulak was Senior Director, Global Regulatory Strategy at Bristol Myers Squibb from 2022 to 2025 and Director, Global Regulatory Strategy there from 2021 to 2022.
Sabrina Gu
LinkedInExperience: Vice President, Head of Regulatory Affairs · Lyell Immunopharma
Sabrina Gu has been Vice President, Head of Regulatory Affairs at Lyell Immunopharma since January 2026, based in the San Francisco Bay Area. Sabrina Gu was Vice President, Head of Regulatory Affairs at Metagenomi Therapeutics from 2024 to 2026 and Vice President, Regulatory Affairs at Grifols from 2022 to 2024.
Choose the right perspective
Match the person's company stage and the kinds of filings they have led to the decision you face, since an early-stage team and a commercial-stage company work differently. Check when each person started the current role to judge how recent their view is.
Questions to take into the conversation
- 01What did you set up first when you took on your current regulatory affairs role?
- 02How have you prepared your team for meetings with regulators in your own programs?
- 03What has your own experience taught you about building a regulatory function at a growing company?
Reaching heads of regulatory affairs
How can I contact one of these heads of regulatory affairs?
Pick one of the 10 people on this page and choose "Book a paid call", or describe your project to find others. You offer a fee for a 15-minute call or a written answer, Instant Expert finds the person's work email and sends the invitation, and they decide whether to accept. The list covers 10 companies, including Marea Therapeutics; Alkeus Pharmaceuticals, Inc. and Crescent Biopharma, based on profile data retrieved on October 22, 2026. Being listed here doesn't mean someone has agreed to take calls.
How much does it cost to reach heads of regulatory affairs?
You choose the offer, starting at $5 per person. The offer is what the person receives, and Instant Expert's fee is added on top, so a $100 offer costs you $125. The fee is 20% of what you pay. You're charged only when the person books the call or sends the answer.
What if they don't reply?
You pay nothing. Instant Expert sends follow-up reminders, and if the person hasn't booked or answered within 7 days, the request expires and any hold on your card is released. You can invite several of the 10 people on this list at once and cap your total spend, so you pay only for the ones who accept.
Can an AI agent ask one of these heads of regulatory affairs a question?
Yes. An agent with a USDC wallet on Base can ask one question without an Instant Expert account. It names the person, for example by the LinkedIn URL on this page, and pays per ask over x402 (HTTP 402). The person answers in writing or by voice note, and if nobody answers within 7 days, the payment goes back to the wallet automatically. Claude and ChatGPT can do the same through the Instant Expert connector: setup is at /docs/mcp for Claude and /docs/chatgpt for ChatGPT. x402 docs
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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