Alene Keller
Senior Manager Regulatory Affairs at Regeneron | Basel Metropolitan Area
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Alene Keller is a highly accomplished Senior Manager in Regulatory Affairs at Regeneron, where she leverages over nine years of specialized experience in the biopharmaceutical industry to drive strategic regulatory initiatives. In her current role, Alene oversees all regulatory activities within Switzerland, serving as the primary point of contact with Swissmedic. Her responsibilities encompass managing the entire lifecycle of regulatory submissions, from initial filings and clinical trial authorizations to post-approval variations and compliance activities. Alene’s deep expertise in RegCMC, labeling, and clinical trial applications (CTA) ensures that Regeneron’s innovative therapies meet stringent regulatory standards while accelerating their path to market.
A key aspect of her role involves leading the company’s regulatory strategy for oncology and biopharmaceutical products, ensuring alignment with evolving global health authority requirements. She actively manages EU clinical trials through the Clinical Trial Information System (CTIS), coordinating with cross-functional teams to facilitate seamless trial approval processes. Her extensive experience working with Swissmedic, combined with her familiarity with EMA and other international agencies, positions her as a vital contributor to Regeneron’s global regulatory landscape.
Alene’s expertise extends into areas such as molecular biology, microbiology, and biowissenschaften, which underpin her understanding of complex biologic products. Her proficiency in regulatory strategy, combined with her technical knowledge in PCR and microbiology, enables her to navigate the intricacies of biopharmaceutical development and ensure compliance with industry standards. Through her leadership, Regeneron continues to advance its pipeline of innovative therapies, demonstrating her commitment to scientific excellence and regulatory integrity.
Senior Manager Regulatory Affairs at Regeneron in September 2023 to Present
Regulatory Affairs Manager at Roche Pharma (Schweiz) AG in October 2020 to August 2023
Regulatory Affairs Officer at Bencard Allergie GmbH in April 2018 to September 2020
Global Regulatory Affairs Associate Manager at Sandoz in January 2016 to March 2018
Scientific Employee at University of Muenster in July 2015 to December 2015
PhD Student at University of Muenster in April 2010 to June 2015
Research Internship at Evonik in August 2007 to September 2007
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University of Münster, Dr. rer. nat., September 2026
University of Münster, Master of Science (M.Sc.), September 2026
University of Münster, Bachelor of Science (B.Sc.), September 2026
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Oncology
Submissions
Swissmedic
CTA
Regulatory Strategy
Health Authorities
Regulatory Affairs
Biopharmaceuticals
Biosimilars
Microbiology
Molecular Biology
Yeast Genetics
RNA Biology
Molekularbiologie
Biowissenschaften
Arzneimittelzulassung
Mikrobiologie
Pharmaindustrie
Biotechnologie
PCR
Western Blot
Biochemie
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Discover more about RegeneronWhat is Alene Keller email address?
Email Alene Keller at [email protected] and [email protected]. This email is the most updated Alene Keller's email found in 2026.
What is Alene Keller phone number?
Alene Keller phone number is +41767999604.
How to contact Alene Keller?
To contact Alene Keller send an email to [email protected] or [email protected]. If you want to call Alene Keller try calling on +41767999604. (updated on April 11, 2025)
What company does Alene Keller work for?
Alene Keller works for Regeneron
What is Alene Keller's role at Regeneron?
Alene Keller is Senior Manager Regulatory Affairs
What industry does Alene Keller work in?
Alene Keller works in the Pharmaceuticals industry.
Alene Keller Email Addresses
Alene Keller Phone Numbers
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