Regulatory Manager
il y a 2 semaines
**About us**:
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 support our clients throughout the full regulatory process, from providing advice on strategy, data requirements and setting up studies, through to preparation of dossiers and any post submission support needed.
**Mission**:
**LOCATION : France (office in Lyon)**
We are currently looking for an enthusiastic and motivated individual to join our expanding REACH Team.
The purpose of this role is to deliver high quality and cost effective services to clients, by providing regulatory consultancy and delivering the client’s regulatory objectives through efficient project management. A comprehensive understanding of the regulatory requirements and process to get chemicals approved in the EU.
You will work closely with the Business Development Managers, Regulatory Managers and Scientific Experts Teams. 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:
- Providing strategic advice to clients relating to REACH and CLP compliance and representing them in communication with Regulatory Authorities
- Managing regulatory projects (including Lead Registrations; REACH audits; Joint submission ‘Member’ dossier preparation etc) and coordinating a multi-skilled project team, to develop robust documentation on behalf of the client
- Providing Only Representative services to Clients
- Various other tasks related to the registration of chemicals in Europe and the UK, including Safety Data Sheet preparation, CLP classification and Poison Centre Notifications
- Providing training in the team
- Developing junior expert(s) within the team
- Representing Staphyt at conferences, possibly as speaker
**Profile**:
Skills and experience required:
**Essential**
- Relevant scientific degree
- At least 5 years experience in REACH sector of the EU regulatory regime, preferably gained within industry and/or consultancy
- Ability to understand and accurately interpret regulatory requirements in order to make appropriate scientific and regulatory conclusions and provide advice and strategy to clients
- Strong knowledge of the REACH and CLP regulations, and processes
- Have a proven track record of building successful relationships with actors in this sector, and also with regulatory authorities
- Good command of key tools (IUCLID)
- Be independent and self motivated, able to work effectively remotely but also integrate closely as part of the geographically dispersed team
- Team player with strong decision-making skills, and keen to work in an international business environment
- Have good attention to detail
- Ability to work in partnership with clients, as well as CROs and other 3rd party suppliers
- Be a good communicator
- A high level of written and spoken English
**Desirable**
- Understanding of, or expertise in other ‘REACH-like’ regulatory frameworks in other jurisdictions, especially K-REACH
- SIEF Management experience would be also appreciated
Flexibility between office and home based can be offered.
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