tali nir
VP clinical and regulatory affairs at Neurim Pharmaceuticals- Claim this Profile
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Bio
Celia McTaggart
I worked with Tali over the course of several years maintaining the EU regulatory approval of an ethical drug in CNS area. Tali is very knowledgeable in the clinical background of the drug and the regulatory requirements in the EU and other major markets. It was always a pleasure working with Tali.
Celia McTaggart
I worked with Tali over the course of several years maintaining the EU regulatory approval of an ethical drug in CNS area. Tali is very knowledgeable in the clinical background of the drug and the regulatory requirements in the EU and other major markets. It was always a pleasure working with Tali.
Celia McTaggart
I worked with Tali over the course of several years maintaining the EU regulatory approval of an ethical drug in CNS area. Tali is very knowledgeable in the clinical background of the drug and the regulatory requirements in the EU and other major markets. It was always a pleasure working with Tali.
Celia McTaggart
I worked with Tali over the course of several years maintaining the EU regulatory approval of an ethical drug in CNS area. Tali is very knowledgeable in the clinical background of the drug and the regulatory requirements in the EU and other major markets. It was always a pleasure working with Tali.
Experience
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Neurim Pharmaceuticals Ltd
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Israel
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Pharmaceutical Manufacturing
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1 - 100 Employee
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VP clinical and regulatory affairs
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Jul 2008 - Present
Accountable for all clinical phase I-IV studies including protocol and CRF writing, CRO selection, study sites selection, tight control on CRO through all study stages, statistical analysis plan writing, report writing. Accountable for the regulation processes for all pharmaceutical products under development including regulatory consultations with regulatory agencies, KOLs, experts and NDA & MAA submissions. Ensuring that all necessary applications are filed and handling all regulatory interactions by managing regulatory relationships with a broad spectrum of regulatory agencies, including FDA, EMA and regulatory agencies in Rest of the World (RoW) countries.Achievements:Leading the clinical development and the regulatory approval of an ethical drug by the EMA (European Medicines Agency). Show less
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Director Clinical and Regulatory Affairs
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Jul 1997 - Jul 2008
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Large Animals Veterinarian
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Feb 1994 - Feb 1997
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Education
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1988 - 1992
Koret School of Veterinary Medicine
DVM, Vetrinary Medicine -
1985 - 1988
Hebrew University Jerusalem
BsC, Agriculture
Community
