Regulatory Affairs Specialist Eu - Antwerpen, België - Draslovka

Draslovka
Draslovka
Geverifieerd bedrijf
Antwerpen, België

1 week geleden

Sophie Dubois

Geplaatst door:

Sophie Dubois

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Beschrijving

Job Summary:


Job description:


  • The primary responsibility is to work with local evaluating competent authorities and with the European registration authorities (ECHA & EFSA) to register and gain approval of biocidal and pesticidal active substances, products and emergency authorisation permits for EU markets.
  • The person must have strong knowledge and experience of the BP and PPP regulations. Experience in registering fumigants are highly preferred.
  • Liaise with regulatory authorities and respond to requests for information and data.
  • The job will also involve work with Overseas registration agencies and consultants for product approval in other countries.
  • Responsible for preparing dossiers for new active substances and formulated products, identify data requirements, assessment of requirements for registration, review the overseas registration data and modify for local submission, organise local scientific trials, identify local testing lab, regular followup with testing lab, gain approval to import product for local trials, attend meetings with registration authority and willing to travel.
  • Preparing a Gantt chart encompassing all activities, responsibilities, and the timelines
  • Maintain regulatory files/database and chronologies in good order.
  • Responsible for timely registration of the product portfolio
  • Maintain current knowledge of local and international regulations, guidance, and standards applicable to the company product portfolio.
  • Be responsible from starting the product scheduling to the final registration certificate of new fumigants, biocides, pesticides, and other chemical products for EU markets.
  • Ability to solve problems, show judgement, pay attention to fine details and make decisions based on sound science and risk analysis.

Qualifications:


  • Bachelor's or Master's degree in biology, toxicology, environmental science, or related field
  • Minimum of 35 years of experience in pesticide, biocide product regulatory affairs in Europa
  • Knowledge of European biocide and pesticide regulations
  • Excellent communication skills and ability to work collaboratively with internal and external stakeholders.
  • Strong analytical and problemsolving skills
  • Fluency in English is required, knowledge of other European languages is an asset.
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