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Alexey Khrenov

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Alexey Khrenov

Research Fellow | Takeda

Maryland, Gaithersburg, United States

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Alexey Khrenov

Summary

Alexey Khrenov is a seasoned Regulatory Affairs leader with over 11 years of experience at the U.S. FDA, specializing in biologics and CMC aspects of regulatory submissions. He has a strong background in managing regulatory review activities, including the establishment of new branches within the FDA's Super Office of Therapeutic Products. His expertise extends to analytical method validation and compliance with cGMP standards. Alexey has actively participated in policy development both within the FDA and in collaboration with international guidance organizations. He holds a Ph.D. in Biochemistry and a Master's in Biophysics, indicating a robust scientific foundation. His leadership skills are complemented by his ability to train and mentor staff effectively. Alexey's career reflects a commitment to advancing regulatory science and improving public health outcomes through effective policy and review processes.

General

Specialist

Technical Background

Leadership Experience

Long-Term Tenure

Immigrant

Professional interests

Industry-specific interests

Emerging Technologies

Leadership Development

Organisational experience

Corporate Experience

Alexey Khrenov

Work Experience

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Director, Global Regulatory Affairs, CMC at

Takeda

September 2025 - Present

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Alexey Khrenov

Education

Institute of Biochemical Physics, Russian Academy of Sciences, Ph.D., Biochemistry

January 1993 - January 1999

Nizhnii Novgorod State University, Master of Science, Biophysics

January 1988 - January 1993

Frequently Asked Questions about Alexey Khrenov

What is Alexey Khrenov email address?

Alexey Khrenov's primary email address is **************@fda.gov. To view the full verified email and additional contact details, sign up for free with Muraena.

What company does Alexey Khrenov work for?

Alexey Khrenov is a Research Fellow at Takeda.

Where Alexey Khrenov graduated from?

Alexey Khrenov holds a degree in null from Institute of Biochemical Physics, Russian Academy of Sciences.

How can I directly contact Alexey Khrenov?

To contact Alexey Khrenov directly, you can use the email address **************@fda.gov. Complete contact information is available upon registration with Muraena.

Is Alexey Khrenov an immigrant?

Yes, Alexey Khrenov is an immigrant and currently based in United States

Who is Alexey Khrenov?

Alexey Khrenov is a seasoned Regulatory Affairs leader with over 11 years of experience at the U.S. FDA, specializing in biologics and CMC aspects of regulatory submissions. He has a strong background in managing regulatory review activities, including the establishment of new branches within the FDA's Super Office of Therapeutic Products. His expertise extends to analytical method validation and compliance with cGMP standards. Alexey has actively participated in policy development both within the FDA and in collaboration with international guidance organizations. He holds a Ph.D. in Biochemistry and a Master's in Biophysics, indicating a robust scientific foundation. His leadership skills are complemented by his ability to train and mentor staff effectively. Alexey's career reflects a commitment to advancing regulatory science and improving public health outcomes through effective policy and review processes.

Alexey`s contact details

mail

**************@fda.gov

********@allmail.net

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