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(Associate) consultant Regulatory Affairs
12-12-2018

#(Associate) consultant Regulatory Affairs

Are you a starting RA professional and looking for career growth?

As a result of the continuous growth of our company and the Regulatory Affairs Division we are looking for a starting professional who like to expand his/her experience in Regulatory Affairs by working in a challenging role as an (associate) consultant RA.


The company


For 25 years Xendo is a leading consultancy organization for the (bio) pharmaceutical industry, medical devices and Life Sciences industry, based near the Bio Science Park in Leiden. In recent years Xendo successfully delivered projects for more than 400 clients. Xendo has an excellent international reputation as a consultancy organization. Most of the work is performed in the Netherlands, Germany and the Nordic Countries, but also on an EU and Worldwide level. Our expertise lies in Regulatory Affairs, Pharmacovigilance, OPEX/Quality Management, Engineering, Qualification & Validation, Product Development and E-Compliance & Data Management.

The environment

Being a consultant you will have the opportunity to work in a wide variety of projects and companies. Assignments may cover all aspects of regulatory affairs ranging from pre-approval and scientific advice meetings to regulatory maintenance, from CMC to regulatory project management and from work on small molecules to high-tech (biological) products.
Depending on your expertise, experience and interest you will be assigned to customers looking for hands-on support and/or requiring advice on regulatory strategic issues. The duration and size of the projects can vary from months to years, from 5 days a week to a couple of hours a month and from working at your own home to the office of the customer. Depending of the project you work within a team or independent, coached by a senior consultant


Your profile


You are an entrepreneur, able to think and act at a scientific level, who is able to quickly adjust to different working environments. A high degree of flexibility in working with different companies and people is required. An open eye for the needs of your customers and the ability to adjust to these needs is essential. At least 1-3 years of experience in regulatory affairs within the pharmaceutical industry or government agency is a requirement.
With these experience you are curious about new opportunities for yourself, the client and Xendo, a self-starter and quick learner with excellent communication skills. Your Dutch and English are fluent.
You aim for a consistent high quality in your work and deliver on your commitments. You are able to manage timelines and prioritize your work. You are well aware of the regulatory legislation, guidelines and directives and are able to assess the impact of changes in this area on the products or portfolio of your customers.
If this profile fits to you and the above environment interest you we encourage you to apply.

Our Offer

We invest in our employees. Such as level-raising courses, subject-specific training courses or courses aimed at personal development. That is good for you and also good for us, when you broaden your knowledge and expertise. There are chances to grow to a higher position means in the first place that you get more responsibility, but your job content also can sometimes change completely. We certainly encourage you to take advantage of all the opportunities you get and show initiative in this.

Information


For more information about the content of the job, you can contact our HR department at 071-524 4000


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