(Senior) Consultant Regulatory Affairs

#(Senior) Consultant Regulatory Affairs

The position

As a result of the continuous growth of our company and the Regulatory Affairs Division we are looking for an experienced professional who like to expand his/her experience in Regulatory Affairs by working in a challenging role as (senior) consultant RA with a coaching function to junior colleagues in a project management setting.

The company

For 25 years Xendo is a leading consultancy organization for the (bio) pharmaceutical industry, medical devices and Life Sciences industry, based at the Bio Science Park in Leiden. In recent years Xendo successfully delivered projects for more than 300 clients. Xendo has an excellent international reputation as a consultancy organization. Most of the work is performed in the Netherlands and Germany, but 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. Besides you will be the coach for associate regulatory affairs consultants and keep track of their work within in the different projects.

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 5-7 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 also 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.

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