Staphyt’s Regulatory Affairs Division supports our clients in bringing Plant Protection, Plant Nutrition, Medicinal, Biocidal and REACh products to the market. We help clients understand and address the EU & GB regulatory requirements for chemical or biological active substances and products.
Our Environment Team is responsible for performing Ecotoxicology, Environmental fate (E-fate) and Environmental Risk Assessment (ERA) work for PPPs, Medicines, Biocides and REACh.
We are currently looking for an enthusiastic and motivated expert to join our multinational Environment Team. The candidate applying for the position must have a strong background in Biocides ERA in the EU. Experience in REACH ERA would be a plus
The expert will work closely with the Environment Team Leader, other Environment Experts, Biocides & REACH Regulatory Managers Teams responsible for the projects, or directly with the Client’s team, delivering the environmental expert work in Biocides and REACh, and contributing to development of the team's skills and work scheduling. A joined-up and consistent approach is needed across all areas of expertise, so proactive communication and strong team working skills are essential.
Main duties:
Drafting of environmental sections of registration dossiers (Biocides & REACh), including preparing study summaries, undertaking the Environmental Risk Assessment (ERA) and higher tier refinements.
Dossier defense.
Data Gap Analysis (DGA).
Where possible, present argumentation for waiving certain studies (Ecotoxicology and/or E-fate).
Study monitoring for Ecotoxicology and/or E-fate studies, involving management of the studies delivered through CROs, budget responsibilities and contact with Clients.
Working as part of a multi-skilled project team, to develop robust documentation on behalf of the Client.
Providing strategic advice to Clients and representing them in communication with Regulatory Authorities.
Skills and experience required:
Relevant scientific degree.
At least 5 years practical experience working full time on the environmental risk assessment of Biocides in the EU, either gained as consultant, regulator, or within industry. REACH ERA experience is a plus.
Ability to understand and accurately interpret data from studies to make appropriate scientific and regulatory conclusions and develop creative and practical solutions where required.
Experience in study monitoring (E-fate and/or Ecotoxicology) is advisable.
Team player with strong decision-making skills, and keen to work in an international business environment.
Ability to work independently.
Good attention to detail.
Be an effective communicator.
A high level of written and spoken English.
This position can be office or home based. Staphyt is present in many European countries.
For more information regarding this role please contact [email protected], or alternatively please submit your CV and a covering letter (both documents in English) at [email protected].
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