Regulatory Affairs Assistant
il y a 2 jours
We strengthen science together
Present in Europe, North Africa, South America, STAPHYT brings together more than 700 employees, of different nationalities and cultures.
Rich in multiple profiles, a wide range of expertise is expressed in the Group, through our areas of activity which are agronomic experimentation, regulatory advice and coordination of registration files.
In a situation of non-stop growing demand, we're working to build the best teams by inspiring, challenging and hiring the brightest talents from all over the World.
Staphyt's Regulatory Affairs Division supports its clients in successfully bringing substances and products to the market. We help clients understand and address the regulatory requirements for chemical or biological active substances and products in Biocides, REACH, Plant Protection & Nutrition sectors. Skills, experience and geographical coverage are three essential assets of our team to enable our clients to achieve their regulatory affairs objectives.
Description du poste :
We are currently looking for an enthusiastic and motivated Regulatory Manager to join our expanding Biocides Team in Europe.
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.
You will work closely alongside our wider Regulatory & Scientific Teams, and directly with the client's team. 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 :
Data Gap Analysis (DGA) including early phase testing strategy for active substance and/or product dossiers
Preparation and submission of BPR dossiers (under IUCLID format)
Application of national registrations under transitional period arrangements
Providing strategic advice to clients and representing them in communication with Regulatory Authorities
Managing major regulatory projects (active substance and product related) and coordinating a multi-skilled project team, to develop robust documentation on behalf of the clients
Various other tasks related to the registration of substances and products in Europe and the UK
Appropriate per review of other team member's work
Description du profil :
Skills and experience required :
Essential :
Relevant scientific degree
At least 5 years experience in Biocides sector of the EU/UK 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, provide advice and strategy to clients
Strong knowledge of the Biocides (BPR) regulation, and processes
Evidence of ability to build and maintain strong and professional relationships with prospective and existing clients
Good command of key tools (IUCLID, R4BP3)
Strategic awareness
Team player with strong decision-making skills, keen to be part of a geographically dispersed team and to work in an international business environment
Ability to work independently
Have a good attention to detail
Be a good communicator
Excellent written and verbal communication skills in English
Desirable :
Knowledge of regulatory frameworks in other jurisdictions (GB BPR, EMEA, LATAM…) or other sectors (REACH, detergents, cosmetics, medical devices, pharmaceuticals, …)
Additional language skills (French, Spanish, German…)
Location :
Belgium/ Europe - Flexible (This position can be office or home based).
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