Pharmaceuticals
10 regulatory affairs experts
These ten professionals have held director-level roles in regulatory affairs at the companies they worked for. A reader can learn how regulatory affairs leaders build and run their teams.
Professionals to explore
01—10Archana Kulkarni
LinkedInExperience: Director Regulatory Affairs · Edwards Lifesciences
Director Regulatory Affairs at Edwards Lifesciences since 2022, and Regulatory Affairs Professional there from 2015 to 2022. The profile says the current role recruits, leads and develops teams to cultivate future leaders and is responsible for Edwards' flagship RESILIA heart valves.
Jonalyn Ongos
LinkedInExperience: Director, Regulatory Affairs · Definium Therapeutics
Director, Regulatory Affairs at Definium Therapeutics since 2024. Former Director, Regulatory Affairs (2024), Associate Director, Regulatory Affairs (2022–2024) and Senior Manager, Regulatory Affairs (2022) at Karuna Therapeutics. The profile describes a focus in CNS drug development and a history of managing regulatory submissions and liaising with health authorities.
Jose de la Cruz
LinkedInExperience: Senior Director, Global Regulatory Affairs (Head of Oxervate Development Lifecycle Management) · Dompé
Senior Director, Global Regulatory Affairs (Head of Oxervate Development Lifecycle Management) at Dompé since 2026, and Director, Global Regulatory Affairs at Dompé from 2024 to 2026. Former Director, Global Regulatory Affairs CMC at Evolus (2022–2024). The profile describes shaping and executing regulatory strategy across biologics, pharmaceuticals, medical devices and diagnostics.
Juan Marquez
LinkedInExperience: North America Director Regulatory Affairs & Global Regulatory Operations · Kimberly-Clark
North America Director Regulatory Affairs & Global Regulatory Operations at Kimberly-Clark since 2024. Former Director Regulatory Affairs-Americas (2020–2024) and Director Global Regulatory Affairs (2018–2020) at Kimberly-Clark. The profile describes setting strategic direction for quality management systems and global regulatory affairs in the global manufacture of medical device, OTC Drug and CE marked PPE, biocides and cosmetic products.
Kristen Wheeler
LinkedInExperience: Director Global Regulatory Affairs · Baxter International Inc.
Director Global Regulatory Affairs at Baxter International Inc. since 2020, with an earlier Director Global Regulatory Affairs role there from 2017 to 2020 and roles as Associate Director (2014–2017) and Senior Manager (2011–2014), Global Regulatory Affairs. The profile describes over 25 years in the pharmaceutical and device industry and setting global strategy and submission development for new, sustaining and geo-expansion programs.
Kulsum Master
LinkedInExperience: Director Regulatory Affairs · Smith+Nephew
Director Regulatory Affairs at Smith+Nephew since 2017. Former Senior Manager Regulatory Affairs (2015–2017) and Senior Regulatory Affairs Specialist (2014–2015) at Smith+Nephew. The profile describes experience in regulatory affairs, quality assurance, research and development and pre-clinical research, plus supervisory experience managing multiple projects simultaneously.
Lillian Yoo
LinkedInExperience: Director of Regulatory Affairs · BD
Director of Regulatory Affairs at BD since 2024. Former Associate Director Regulatory Affairs (2022–2024), Senior Program Manager - Regulatory Affairs (2018–2022) and International Regulatory Affairs Manager (2015–2018) at BD. The profile describes expertise in regulatory operations, program management and international regulatory affairs, including European MDR/IVDR, BREXIT and MDSAP.
Masooma Razvi
LinkedInExperience: Director Global Regulatory Affairs · Pfizer
Director Global Regulatory Affairs at Pfizer since 2022. Former Senior Manager Regulatory Affairs (2019–2022) and Senior Regulatory Affairs Associate (2017–2019) at Pfizer. The profile cites communicating effectively with regulatory agencies and working within matrix and cross-functional teams, and mentions obesity, type 2 diabetes mellitus, heart failure and oncology across small molecules and biologics.
Raymond P. Silkaitis
LinkedInExperience: Director Regulatory Affairs, Devices · Amgen
Former Director Regulatory Affairs, Devices at Amgen (2013–2023). Former Director, Worldwide Regulatory Affairs at Merck (2012–2013) and Director Global Regulatory Affairs at Hospira (2001–2012). The profile describes an experienced Director of Regulatory Affairs with a demonstrated history of working in the biotechnology industry.
Tealman Bjoraker
LinkedInExperience: Director of Regulatory Affairs · Medtronic Cranial and Spine Therapies
Director of Regulatory Affairs at Medtronic Cranial and Spine Therapies since 2024. Former Brain Therapies RA Program Manager, Sr. RA Program Manager (2018–2021) and Restorative Therapies - Implantables Principal Regulatory Affairs Specialist (2015–2018) at Medtronic. The profile describes experience with Class II and III devices, FDA submissions such as 510 (k) and PMA, and implementing advocacy and policy programs.
Choose the right perspective
Match the person's product type to yours, since drugs, biologics and medical devices follow different regulatory pathways. Also decide whether you need help with a single market or with global strategy across several regions, and pick someone whose titles cover that scope.
Questions to take into the conversation
- 01How do you decide on a regulatory pathway early in development, and what makes you change course?
- 02How do you prepare a team for a major meeting or submission with a health authority?
- 03Which parts of regulatory work do you keep in-house and which do you hand to outside partners, and why?
Reaching regulatory affairs experts
How can I contact one of these regulatory affairs experts?
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 Edwards Lifesciences, Definium Therapeutics and Dompé, based on profile data retrieved on October 4, 2026. Being listed here doesn't mean someone has agreed to take calls.
How much does it cost to reach regulatory affairs experts?
You choose the offer, starting at $5 per person. It includes Instant Expert's 20% fee, so an offer that pays the person $100 costs you $125. 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.
About this directory
This is a professional research starting point based on business profile data retrieved on . Titles and companies reflect that source snapshot and may describe past or present roles. Check the linked profiles for current details. Inclusion does not imply Instant Expert membership or availability.
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