Kinesis Pharma is currently looking for a Consultant Regulatory Affairs with at least 6 years experience in Regulatory Affairs for medicinal products and with experience or affinity for business development. The Regulatory Affairs department within Kinesis Pharma is involved in a broad range of activities of regulatory affairs for Europe and US: consultancy on regulatory strategy towards sponsors or towards projects running within Kinesis Pharma, assisting sponsors in various types of applications, like scientific advice/(pre)IND procedures, PIPs, orphan drug applications, US NDAs or EU (de)centralised procedures, and traditional herbal drug applications. The Asian region has our attention.

The Consultant Regulatory Affairs will participate in project teams and contribute to development plans. He/she will be responsible for strategic advice on regulatory issues and preparation of the necessary application documents within the specified timelines. You will be responsible for all communications to the regulatory authorities during the process and participate in meetings between the sponsor and regulatory authorities. You will coordinate the writing of the scientific parts with other departments within Kinesis Pharma and out-source activities to third parties whenever needed. You will report to the Director Regulatory Affairs and participate in business development of the regulatory affairs department.

We are looking for a candidate with an academic degree in pharmaceutical sciences and a minimum of 6 years experience in regulatory affairs, preferable within a CRO environment. You have excellent knowledge of European procedures and guidelines and preferable also with those of other countries, like US. You can work within a team and coordinate your projects with other employees of Kinesis Pharma within the sponsor timelines. You are capable of building good relationships with our clients. Your communication skills in Dutch and English are excellent.

The function is for a minimum of 24 hours per week, with flexibility from both sides. We offer an employment with excellent primary and secondary conditions. In our organization you can acquire a high level of responsibility and independency, broaden your knowledge, experience and expertise and work in close collaboration with our other development departments.

For more information you may send an e-mail to Peggy.IJzelman@Kinesis-Pharma.com. Your letter of application and CV may also be sent by e-mail to this address or by regular mail to: P. IJzelman, Kinesis Pharma BV, Lage Mosten 29, 4822 NK Breda, The Netherlands.