Regulatory Trainee/Document Specialist
Staphyt’s Regulatory Affairs Division supports our clients in bringing plant protection, plant nutrition, biocide and REACH chemical products to the market. We help clients understand and address the EU & UK regulatory requirements for chemical or biological active substances and products.
We are currently looking for an enthusiastic and motivated individual, to support the regulatory team. The Regulatory Trainee will provide support to project managers by undertaking specific essential tasks relating to document management, data entry and literature searching.
This is an entry level position, with the possibility for career progression as experience grows. You will have the opportunity to attend internal training and your work will give you a good introduction to chemical and biological regulatory affairs.
- Using databases to identify scientific peer-reviewed open literature in line with EFSA guidance, as required by Article 8(5) of Regulation (EC) No 1107/2009 on the placing of plant protection products on the market
- Assisting the project manager and project team to refine the search terms used and to write the literature review and the associated tools
- Managing scientific bibliographies under project manager supervision through dedicated software tool to obtain relevant publications (toxicology, residues, efate, ecotoxicology)
- Setting up standard folder structures for projects (e.g. eSubmission)
- Recording and organising client’s scientific data as it is received
- Improving our data management process and ensuring that data is reviewed and securely destroyed or returned to the client in accordance with our contractual obligations.
- Recording and maintaining the details of studies in the EFSA notification of intended studies (NOIS) database, under the close supervision of the project manager.
Depending on your skills and experience, you may be trained in specific regulatory task for clients such as:
- Download of dossier reference lists and administrative check of consistency with dossier.
- Poison Centre Notifications
- Preparation of Safety Data Sheets and label
- Assistance with submissions through IUCLID
- Project planning support for project managers using Oracle software (‘NetSuite’).
- Supervision of document translation when required for clients (text labels, certificates, etc).
Skills and experience required:
- A degree in a relevant discipline (e.g. scientific).
- High level of accuracy and attention to detail.
- Tenacity to read and understand large volumes of information (e.g. regulatory guidance documents).
- Ability to make well thought out recommendations regarding improvements in our data archiving procedures.
- You will be a good team player and have the confidence to interact with other team members at all levels and locations.
- Excellent written and verbal communication skills (our business language is English).
- Previous experience of working in regulatory affairs in at least one of the sectors above.
- An understanding of GDPR.
- As understanding of formal project management techniques, or PMO experience.
- Intercultural experience and/or knowledge.
- A second European language is beneficial.
This position will be office based and you will work from one of our main regulatory offices (UK - Wetherby, or France - Lyon), where you can be trained and supported by colleagues. However, home working may be necessary initially due to the current COVID-19 pandemic.
For more information regarding this role please contact: email@example.com, or alternatively please submit your CV and a covering letter (both documents in English) to: Mélodie DUPARD at firstname.lastname@example.org.