General Statement of Responsibility
This position is accountable for human health risk assessment for acquiring and maintaining registrations (e.g. BPR, REACH) in Europe. For more information you can contact Laura Nagelschmidt, human resources ( email@example.com ).
- Human health risk assessment to support any relevant registrations to support the sales and marketing of new and existing Troy products in Europe by ensuring compliance with EEA and country specific legislation.
- Development, review, supervision and coordination of toxicological in vitro, in vivo and in silico studies required for European registration of Troy products.
- Conduct and/or coordinate ED assessments according to the ECHA/EFSA criteria
- Coordinate with U.S Corporate Headquarters on meeting the EU and/or global regulatory requirements for all Troy active substances, biocidal products as well as additives.
- Work with European staff on the maintenance and development of Safety Data Sheets meeting European requirements (e.g. EU REACH (EC 1907/2006), EU CLP (EC 1272/2007) and related regulatory frameworks).
- Develop and maintain data management systems for relevant European study data (e.g. (eco)toxicological, phys-chem, efficacy, environmental fate and analytical) as well as country specific requirements.
- Represent Troy in national and/or European trade associations, working groups and committees.
- Represent Troy before Regulatory and Legislative government agencies.
Education, Experience, Demeanor:
- PhD in toxicology (or comparable; e.g. Board Certified Toxicologist, ERT, DABT) with five to ten years’ working experience in chemical industry and/or relevant competent authorities in the area of European chemicals management Regulatory Affairs.
- Proven track record of successful testing strategy development and study monitoring to support EU regulatory dossier development and submission (using IUCLID6, R4BP and REACH-IT)
- Team player with ‘can do’-mentality; a strong communicator, who is flexible and self-starting with proven project management and project co-ordination skills.
- On time in full delivery of human health risk assessments as well as assessments related to endocrine disruption and hazard classification
- On time in full product compliance with the relevant national and European regulatory frameworks.
- Coordination of relevant toxicological testing efforts for on time in full deliver for the relevant European registration requirements.
- On time in full compliance with the relevant EU regulatory frameworks applicable to product Safety Data Sheets.
- Involvement in European groups and committees aligned with the Troy Regulatory Advocacy Strategies
Supervision Given and Received:
Works under Director of Regulatory Affairs Europe
- Director Sales & Marketing Europe
- Director Environmental Resources, USA
- Product Registration Department, USA
- Vice President Science & Technology, USA
- Senior Vice President Global Regulatory Affairs, USA
- Troy Europe Personnel
- European Competent Authorities
- International Law Firms
- European customers
- Contract Research Organisations
- EU citizen or have all relevant work permits to work in EEA countries.
- Fluent in English and speak at least one other European language (knowledge of Dutch or German is highly appreciated).
- Role is full time (1FTE) with a competitive salary and additional benefits.
- Role will be based in our Troy offices in Delft, The Netherlands or Hanover, Germany.
- Travel might be required for a maximum of 20% of the working time.