Charlotte Klank

Head of Regulatory Affairs | Supply Chain | Communications at Aphea.Bio
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Contact Information
us****@****om
(386) 825-5501
Location
Germany, DE
Languages
  • German Native or bilingual proficiency
  • English Full professional proficiency
  • French Elementary proficiency

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Experience

    • Belgium
    • Biotechnology Research
    • 1 - 100 Employee
    • Head of Regulatory Affairs | Supply Chain | Communications
      • Nov 2022 - Present

      Expansion of Head of Regulatory Affairs & Communications as part of the Aphea.Bio management team.Head of Supply Chain activities include:• Defining supply chain management at Aphea.Bio• Establishing commercial manufacturing in cooperation with Development & Business Functions• Coordination of demand planning for commercial production• Warehouse & logistics management for both development & commercial purposes (research material and commercial product)

    • Head of Regulatory Affairs | Communication
      • Sep 2021 - Nov 2022

      Implementation of regulatory affairs in a fast growing start-up and planning & implementing registration strategies for biocontrol & biostimulants. Head of Regulatory Affairs key activities include:• Providing strategic guidance on regulatory trends to management.• Development & implementation of a stage-gate process from discovery to market launch• Defining criteria to assess registrability of candidates in all stages.• Providing guidance across functions on requirements for efficacy, manufacturing, mode of action etc.• Coordination & execution of registration plans.• Establishing quality assurance and building EHS.Communications key activities include:• Establishing a communications strategy to support Series C founding and to increase awareness of Aphea.Bio.• Rebranding of Aphea.Bio.• Creation & management of digital strategy.• Selection & coordination of marketing agencies for activities. Show less

    • Israel
    • Farming
    • 700 & Above Employee
    • Global Regulatory Affairs Manager
      • Oct 2020 - Aug 2021

      Building & implementing global strategies for active substances and associated products and leading a cross-functional team to efficiently achieve market authorizations. Key activities included: • Active tracking of regulatory trends & assessing their impact on the product portfolio. • Coordination & management of study packages across scientific disciplines including budget accountability. • Ensuring alignment with all involved stakeholders across functions and global regions. Building & implementing global strategies for active substances and associated products and leading a cross-functional team to efficiently achieve market authorizations. Key activities included: • Active tracking of regulatory trends & assessing their impact on the product portfolio. • Coordination & management of study packages across scientific disciplines including budget accountability. • Ensuring alignment with all involved stakeholders across functions and global regions.

    • United States
    • Chemical Manufacturing
    • 700 & Above Employee
    • EMEA Regulatory & Development Leader Plant Health
      • Nov 2018 - Sep 2020

      Accountable for EU active substance and product submissions in EMEA for microbial biopesticides, national product registration of biostimulants as well the crop nutrition portfolio across EMEA.Working in a cross-functional, global and regional teams on achieving an accelerated introduction of novel biopesticide solutions.

    • R&D Leader MEA & EE
      • Nov 2017 - Oct 2018

      Providing regulatory intelligence to business leaders in a diverse landscape as well as leading a multi-national, virtual team of product registration experts in Eastern Europe, Middle East and Africa to execute global business strategies

    • United States
    • Manufacturing
    • 700 & Above Employee
    • R&D Manager Nordics and Non-EU countries
      • May 2017 - Nov 2017

      Leading a multi-national team of registration & field development colleagues responsible for product submissions across Northern & Eastern Europe and Africa during the transitional phase from DuPont to FMC as well as supporting business colleagues in the execution of strategic business plans.

    • Registration & Development Supervisor DACH
      • Jan 2015 - May 2017

      Leading a team of registration and field development specialists responsible for product submissions in Germany, Austria and Switzerland as well as working in close collaboration with business leaders to ensure alignment on strategic decisions and supporting commercial activities.

    • United Kingdom
    • Research
    • 400 - 500 Employee
    • Team Lead Terrestrial Ecotox
      • Aug 2013 - Dec 2014

      Team lead for terrestrial ecotox laboratory group, leading both study directors and technicians in the execution of various study types.

    • Study Director Terrestrial Ecotox Lab
      • May 2012 - Dec 2014

      Study director for terrestrial ecotox studies, especially non-target arthropod, non-target plant and bee larvae studies.

Education

  • ETH Zürich
    Dr. sc (ETH Zurich), Ecology, Evolution, Systematics, and Population Biology
    2006 - 2011
  • The University of Queensland
    Ecology, Evolution, Systematics, and Population Biology
    2002 - 2002
  • Georg-August-Universität Göttingen
    Diploma (Dipl. Biol.), Biology
    1999 - 2005
  • Max Planck Society
    Internship, biophysical chemistry
    1999 - 1999

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