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For more than ten years I
have managed and lead processes involving international
regulations, quality assurance and product development in the
field of food and dietary supplements.
During the last few years I
served as Regulatory Affairs Manager for Enzymotec, a global
biotech company, where I specialized in leading regulatory
processes from idea to successful
pre-marketing approval and gained extensive knowledge and
valuable experience.
As the Regulatory Affairs
Manager I was also responsible for providing full in-process
and post-marketing regulatory support to the company's
divisions and customers.
My experience includes
leading processes such as preparation and submission of GRAS
and NDI notifications, Novel Food applications, health claim
submissions as well as other types of pre-market applications
in Europe, USA, Australia, China, Japan, India, Korea and
Israel.
I hold a Master of Science
degree in Biotechnology (Cum Laude) and a Bachelor of Science
degree in Food Engineering & Biotechnology, both from the
Technion Institute in Israel.
Services
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Determination of the
product’s regulatory status.
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Identifying the relevant
regulatory tracks in the targeted states.
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Setting strategy to
obtaining pre-market approval or freedom to operate.
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Management, preparation
and submission of regulatory files (GRAS, NDI, Novel Food
and others).
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Defining and approving
claims associated with the product.
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Providing regulatory
insights during product development.
Contact details
Tel:
972-54-5315999
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