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Regulatory Affairs Specialist (macro)

Posted 24 Mar 2024
Work experience
3 to 5 years
Full-time / part-time
Full-time
Job function
Degree level
Required languages
English (Good)
Dutch (Fluent)

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Beschrijving van het bedrijf

Koppert, a successful family company

Koppert Biological Systems is an international market leader when it comes to biological crop protection, natural pollination and sustainable cultivation systems. Natural enemies, microorganisms, and biostimulants ensure that the crop is healthy, resilient and vital; both above ground and the root system environment. Our bumblebees take care of the natural pollination of crops. In this manner, we offer our customers a strong and sustainable alternative to chemical crop protection. Koppert has approximately 1500 employees, of whom 500 work in the Netherlands. The head office is in Berkel and Rodenrijs, close to Rotterdam and The Hague, and is easy to reach by public transport. Koppert has 25 subsidiaries worldwide.

Functieomschrijving

Are you a result oriented team player with solid analytical skills and are you up for a new step in a challenging international oriented career?

…. Apply now!

Koppert Biological systems has a position for you as:

Regulatory Affairs Specialist (Macro)

40 hours per week

This is a key position!

In this position you provide global regulatory support to various projects, products and colleagues. You contribute to the process of obtaining and maintaining product registrations, Phyto-sanitary/veterinary or other documentation and related activities for obtaining market access for Kopperts’ products (in the field of insects, mites and bumble bees), ensure the application of standards and provide advice and support to management about regulatory affairs issues in line with the Product Management, R&D and Regulatory Affairs strategy and relevant legislation. You do this in order to support early product registration as well as effective maintenance of existing licenses and to protect the reputation of Koppert.

This includes the following duties/responsibilities:

  • Develop, write and coordinate the creation of new global regulatory dossiers for macro biocontrol solutions;
  • Write, coordinate and complete the submission of regulatory documents to (inter)national authorities;
  • You analyze business developments and you proactively suggest Regulatory activities in relation to our market access within the Horti- and Agribusiness worldwide;
  • Prepare responses to (inter-) national legislation facilities questions and other regulatory correspondence;
  • Provide regulatory support to product development teams which includes in-depth team involvement with core team members (e.g. marketing, R&D). Guide and train your team members.
  • Build and maintain professional relationships with regulatory authorities, consultants and specialists to shape the regulatory environment;
  • Support the development, implementation and evaluation of Regulatory Affairs procedures, processes, standards and systems, evaluate bottle necks and/ or compliancy risks and support the implementation of improvements.

The duties and responsibilities for this position will evolve over time as Regulatory Affairs is of increasing importance for Koppert, because of the need for registration of Kopperts’ products. As Koppert is one of the leading companies in the industry, there is an important role for this department in influencing policy makers, to ensure that (inter)national legislation facilitates future innovations and protects the environment and wellbeing of human and nature.

We are looking for an enthusiastic colleague to join this team on the journey to build our business forwards into the future. Our team consists currently 9 professionals (Regulatory Affairs, Legal Affairs and Public Affairs). The cooperation within our teams is informal, as is the general atmosphere. We help each other to get the best solutions for our clients.

Functie-eisen

Your profile:

  • Master degree, preferably in Biology, with high affinity of insects, mites and/or bumble bees;
  • At least 3 years work experience in a similar position within authorities, consultancy agencies or industry;
  • You are known as a talented problem solver who is able to communicate effectively in English and Dutch (additional languages are plus) and built relationships with different people from different cultures;
  • Capable to persuade and convince others to another point of view or opinion - by using the right and balanced set of arguments, facts, emotions, metaphors, choice of words;
  • You are also an inspiring and optimistic person who likes to work together with the team to get the job done;
  • Ability to handle and combine diverse information streams without losing overview and end-goal in mind. Identify key issues of a project or subject, identify consequences and how to proceed;
  • You live in the Netherlands and you are willing to travel sometimes.
  • Eagerness to learn about different Regulatory Affairs challenges worldwide and make sure that you are a business partner for international colleagues in those projects.

Extra informatie

We offer you:

Koppert Biological Systems is a good employer who supports sustainability. The working atmosphere is informal. We are a family company. We are closely involved with everything that happens within and outside our company and are constantly looking at ways of improvement. This has made us pioneers in the international market when it comes to biological crop protection and sustainable cultivation systems.

  • The opportunity to work for an international, growing company that is an important player in the field of sustainability;
  • The possibility to develop yourself in the field of Regulatory Affairs supported by training facilities in cooperation with the Koppert Academy;
  • A Dutch fixed term employment agreement of one year;
  • Laptop and cell phone are provided so you are flexible to work where needed;
  • 28 days holiday (fulltime).

To make our world more sustainable, we need ways of growing that are both safe and healthy. We believe the answers to these agricultural challenges lie in nature itself. So we partner with nature. And help our planet to find its balance. Using natural enemies to combat pests, bumblebees for pollination, microbials, and biostimulants that support, protect, and strengthen crops. Improving plant health both above and underground.

Agriculture
Berkel en Rodenrijs
Active in 30 countries
3,000 employees
50% men - 50% women
Average age is 35 years