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Senior Registration Specialist

SIRE Life Sciences®

Netherlands, zagranica

SIRE Life Sciences®

Senior Registration Specialist

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Pharmaceutical organization, based in Noord-Holland Netherlands.

Based in Diegem (Brussels) our client a subsidiary of the Japanese parent company. They were founded in Japan in 1920 and has been in the chemical business for over 80 years and in the crop protection business since the 1950s.

ROLE DESCRIPTION

The Regulatory Affairs Team has primary responsibility for approval / renewal active substances at EU level under Regulation 1107/2009 and for the processing of applications to obtain, maintain and renew registrations for plant protection products in the EMEA region.

RESPONSIBILITIES

Substance responsibility
• Responsible for one, or more, active substances of the company.
• Address all registration requirements in order to obtain/maintain approvals of active substance(s) at the EU level and formulated products at the
national level.
• Provide assistance to other Team Members for any specific requirements/questions related to the assigned substance.

Country responsibility
• Is responsible for one, or more, country in the EMEA region
• Maintain existing approvals of formulated products approved in countries your responsible for through registration requirements.
• In the same order as above, extent the approved uses of formulated products in the assigned country(ies) in accordance with the internal deadlines.
• Moreover, address registration requirements in order to obtain the approval of new formulated products in the assigned country(ies); zonal approvals, national approvals, mutual recognition, etc. in accordance with the internal deadlines.

Expertise responsibility
• Expert in one of the following fields: physico-chemistry, analytical method, toxicology, residues, environmental fate, ecotoxicology, agronomy
• Good overview of all the sections of a dossier and is able to manage and supervise the preparation of sections
• Assist the other Team Members to solve all technical issues related to her/his area of expertise for both active substances and formulated products.
• Monitor the studies in her/his area of expertise
• Prepare rebuttal documents when required
• Provide advices in order to fit with the best regulatory strategy

REQUIREMENTS

Essential
• Minimum of a Master degree in agronomy or sciences (such as, but not limited to, toxicology, ecotoxicology, environmental-fate)
• Previous experience (four to six years) with legislative and regulatory process in plant protection is especially helpful.
• Sound knowledge of guidelines (study conduct and assessment) for at least one specific area of the dossier.
• Flexibility, assertiveness and ability to independently and efficiently work in an interdisciplinary and international team

Highly Desirable
• Fluent in English; additional language skills would be an asset
• Self-motivated

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees van Wezel.

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SIRE Life Sciences®

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