Maria Fernandez
Client lead to multiple US and European companies for regulatory development programmes, designing and implementing the regulatory strategy... | Cambridge, England, United Kingdom
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Maria Fernandez’s Emails ma****@ya****.es
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Maria Fernandez’s Location Cambridge, England, United Kingdom
Maria Fernandez’s Expertise Client lead to multiple US and European companies for regulatory development programmes, designing and implementing the regulatory strategy for therapeutic assets. Leading interactions with regulatory agencies across submissions and meetings. Defining and leading the regulatory strategies from early stage development to marketing authorisation in a wide range of therapeutic areas including oncology, immuno-oncology, metabolic diseases, ophthalmology and infectious diseases. Biologics specialist, experience with advanced therapies medicinal products, including CAR T and AAV-based therapies. Expert guidance to clients for scientific advice, orphan designation applications, PIP applications, PRIME applications, gap analysis and Regulatory Roadmaps. Specialist programme manager EU CTA and GMO applications for ATMPs clients. EMA and FDA interactions. Winner of TOPRA Futures Award 2018 in recognition of an excellent regulatory contribution and achievement supporting Kite Pharma on the YESCARTA (CAR T programme).
Maria Fernandez’s Current Industry Astrazeneca
Maria
Fernandez’s Prior Industry
Universidad De Oviedo
|
University Of Cambridge
|
Phico Therapeutics
|
Diamond Pharma Services
|
Astrazeneca
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Work Experience
Astrazeneca
Regulatory Affairs Director-Oncology
Sat May 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Diamond Pharma Services
Associate Director of Regulatory Affairs
Tue Jan 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat May 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Diamond Pharma Services
Senior Biologics Development Manager
Sun Jan 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Diamond Pharma Services
Biologics Development Manager
Tue Mar 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Phico Therapeutics
Process Development Senior Scientist
Thu Sep 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Mar 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
University Of Cambridge
Post Doctoral Research Associate
Mon Jan 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Sep 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)
Universidad De Oviedo
Post Doctoral Research Associate
Sat Jan 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Dec 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time)Skills
Languages
Maria Fernandez Email Addresses
FAQ About Maria Fernandez
-
Maria Fernandez is located at
Cambridge, England, United Kingdom -
Maria Fernandez is a
Client lead to multiple US and European companies for regulatory development programmes, designing and implementing the regulatory strategy for therapeutic assets. Leading interactions with regulatory agencies across submissions and meetings. Defining and leading the regulatory strategies from early stage development to marketing authorisation in a wide range of therapeutic areas including oncology, immuno-oncology, metabolic diseases, ophthalmology and infectious diseases. Biologics specialist, experience with advanced therapies medicinal products, including CAR T and AAV-based therapies. Expert guidance to clients for scientific advice, orphan designation applications, PIP applications, PRIME applications, gap analysis and Regulatory Roadmaps. Specialist programme manager EU CTA and GMO applications for ATMPs clients. EMA and FDA interactions. Winner of TOPRA Futures Award 2018 in recognition of an excellent regulatory contribution and achievement supporting Kite Pharma on the YESCARTA (CAR T programme). Astrazeneca -
Maria Fernandez currently works in the
Astrazeneca -
Maria Fernandez specializes in
Client lead to multiple US and European companies for regulatory development programmes, designing and implementing the regulatory strategy for therapeutic assets. Leading interactions with regulatory agencies across submissions and meetings. Defining and leading the regulatory strategies from early stage development to marketing authorisation in a wide range of therapeutic areas including oncology, immuno-oncology, metabolic diseases, ophthalmology and infectious diseases. Biologics specialist, experience with advanced therapies medicinal products, including CAR T and AAV-based therapies. Expert guidance to clients for scientific advice, orphan designation applications, PIP applications, PRIME applications, gap analysis and Regulatory Roadmaps. Specialist programme manager EU CTA and GMO applications for ATMPs clients. EMA and FDA interactions. Winner of TOPRA Futures Award 2018 in recognition of an excellent regulatory contribution and achievement supporting Kite Pharma on the YESCARTA (CAR T programme). -
Maria Fernandez speaks the following languages:
No languages available. -
Maria Fernandez has prior experience in the following industries:
Diamond Pharma Services , Diamond Pharma Services , Diamond Pharma Services , Phico Therapeutics , University Of Cambridge , Universidad De Oviedo -
Maria Fernandez has the following professional experience:
Astrazeneca , Diamond Pharma Services , Diamond Pharma Services , Diamond Pharma Services , Phico Therapeutics , University Of Cambridge , Universidad De Oviedo . -
You can view Maria Fernandez’s
LinkedIn profile at LinkedIn URL. -
Maria Fernandez’s work email addresses are
[email protected] . -
Maria Fernandez works at
Astrazeneca
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