Beata Bialek
Regional Regulatory Manager - Herbicides at UPL EUROPE LTD- Claim this Profile
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Polish Native or bilingual proficiency
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English Full professional proficiency
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Bio
Experience
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UPL EUROPE LTD
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United Kingdom
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Chemical Manufacturing
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1 - 100 Employee
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Regional Regulatory Manager - Herbicides
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Jul 2019 - Present
Responsible for managing of the allocated herbicides in EU and some in CIS countries.
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Regulatory Manager
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Feb 2009 - Jul 2019
Responsible for all UPL registrations in Poland, Czech and Slovakia under Regulation 1107/2009. Previously also responsible for Hungary. The role involveso Close liaison and negotiation with regulatory authorities. Sole person within UPL responsible for all authority liaison for the above countrieso Team working with Sales, Marketing and others within the European Regulatory Team. Responsible to take the ideas of Sales and Marketing teams and turn them into regulatory strategy and product approvalso Portfolio included over 45 products in Poland and over 50 in Czech and Slovakia. Included new products (Article 33), product renewal (Article 43), label extensions, back-to-backs, mutual recognitionso Label preparationEuropean product regulatory responsibility for 2 products. The role involveso Organisation of writing and submission of dossiers across Europeo Managing a programme of studieso Liaison with active substance Regulatory Managers
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International Registration Officer
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Jan 2001 - Jan 2009
Preparation of registration dossiers and MSDS’s for pesticides in various countries including: South Africa and other African countries (Ghana, Sudan, Nigeria, Cameroon, Tanzania, Kenya, Burkina Faso), Romania, Moldova Preparation of registration dossiers and MSDS’s for pesticides in various countries including: South Africa and other African countries (Ghana, Sudan, Nigeria, Cameroon, Tanzania, Kenya, Burkina Faso), Romania, Moldova
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Regulatory Affairs Specialist
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Apr 1998 - Dec 2000
• Preparation of Annex II and Annex III EU dossiers (Directive 91/414/EEC) for registration of Acetochlor and safener• Coordination of the dossier preparation with the Monsanto’s experts• Preparation of the Pre and Main Notification for Acetochlor to be submitted to the European Commission • Preparation of Annex II and Annex III EU dossiers (Directive 91/414/EEC) for registration of Acetochlor and safener• Coordination of the dossier preparation with the Monsanto’s experts• Preparation of the Pre and Main Notification for Acetochlor to be submitted to the European Commission
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Product Data Manager
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Jan 1994 - Mar 1998
Responsible for the registration of Sanachem’s pesticides and management of the scientific data packages of those pesticideso Compilation of the registration dossiers, product’s overviews and MSDS’so Identifying gaps in product data packages, contracting out scientific studies to fill the gaps, approving protocols of contracted studies as well as draft and final reportso Updating product data bases with respect to toxicology, ecotoxicology, physical-chemical properties, environmental fate, efficacy and residue information o Budgeting and controlling expenditure of contracted studies
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Biology Teacher
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Jan 1985 - Jan 1994
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Education
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Uniwersytet Przyrodniczy we Wrocławiu
Master of Science (MSc), Agricultural Engineering