REGULATORY MANAGER - PPP

Staphyt; Berlin; Hybrid; EUR 50.000 - 80.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen sucht einen engagierten Regulatory Manager mit umfassender Erfahrung in der EU & UK Pflanzenschutzregulierung. In dieser spannenden Rolle sind Sie verantwortlich für die Vorbereitung und Einreichung von Dossiers, die strategische Beratung von Kunden und die Leitung bedeutender regulatorischer Projekte. Das Unternehmen bietet die Möglichkeit, flexibel im Homeoffice oder im Büro zu arbeiten, und fördert eine enge Zusammenarbeit in einem internationalen Team. Wenn Sie eine Leidenschaft für regulatorische Angelegenheiten haben und in einem dynamischen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Qualifikationen

• 5-10 Jahre Erfahrung in EU & UK Regulatory Affairs für Pflanzenschutz.
• Fähigkeit, regulatorische Anforderungen zu verstehen und zu interpretieren.

Aufgaben

• Vorbereitung und Einreichung von Pflanzenschutzdossiers gemäß nationalen oder EU-Anforderungen.
• Strategische Beratung für Kunden und Vertretung in der Kommunikation mit Behörden.

Kenntnisse

Regulatory Affairs

Project Management

Communication Skills

Teamwork

Attention to Detail

Ausbildung

Relevant Scientific Degree

Tools

IUCLID

EFSA.Portal

Jobbeschreibung

We strengthen science together!

Present in Europe, North Africa, South America, STAPHYT brings together more than 600 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.

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 regulatory requirements for chemical or biological active substances and products.

We are currently looking for an enthusiastic and motivated German speaker individual based in Germany, with experience in EU & UK Plant Protection Regulatory Affairs (chemical & biological), to join our multinational PPP regulatory managers team.

This role has this main purpose:

* To deliver, as Regulatory Manager, 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 active substances and plant protection products approved in the EU and UK is therefore appreciated.

You will work closely with the other Plant Protection Regulatory Managers, the BD team, the scientific experts and local national 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 :

• Preparation and submission of plant protection dossiers according to national or EU requirements.
• 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 client.
• Working with the wider team to estimate the resources needed to deliver projects for our clients. Coordinating the provision of quotes.
• Various other tasks related to the registration of plant protection products in Europe and the UK.

Your profile

Essential

• Relevant scientific degree.
• German speaker.
• At least 5 to 10 years experience in EU UK regulatory affairs for PPP, ideally in preparing dossiers, as background understanding for this role.
• 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 plant protection products regulations in several countries and the EU, and processes.
• 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 :

• Knowledge of IUCLID.
• Knowledge of EFSA.Portal (Notification of Studies).
• Knowledge of other regulatory frameworks (such as biocide (BPR) regulation, fertilizers, soil improvers, growing media and biostimulants processes) within the EU and outside the EU.

LOCATION : Europe - Flexible - Home working is possible.

This position can be office or home based.

Staphyt is present in many European countries.

Competitive salary (negotiable) Permanent contract / As soon as possible.