Vacancies

Kinesis Pharma B.V. provides drug development solutions to sponsors through consulting and contract research services. A premium is placed on the provision of high quality services by combining expert knowledge and experience with cutting edge technology, packaged with efficiency. Steady, self-perpetuating organic growth of the business over the past decade, based on an impeccable reputation in the industry, sees Kinesis Pharma B.V. positioned as a medium sized enterprise with sustainable, ambitious aspirations.

The departments within Kinesis are modeled on the classical disciplines of drug development including clinical, non-clinical, chemistry manufacturing and control, and regulatory and project management. Within the regulatory department a team of consultants and medical writers supports sponsors in their (early) development projects. Over the last ten years this team has supported strategic regulatory decisions, operational support in registration procedures and in writing application dossiers or other regulatory documents. The Asian region and traditional herbal medicinal products have our attention.

The Senior Consultant Regulatory Affairs will be involved in a broad range of activities of regulatory affairs for Europe and US: consultancy on regulatory strategy, assisting sponsors in various types of applications, like scientific advice/(pre)IND, pediatric plans, orphan drug applications, US NDAs/BLAs or EU (de)centralised procedures.

The Senior Consultant Regulatory Affairs will participate in project teams and contribute to drug development plans. You 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 outsource activities to third parties whenever needed. You will report to the Director Regulatory Affairs and participate in business development of the regulatory affairs department.

A successful candidate holds a university degree in life science or pharmaceutical science combined with at least 6 years of relevant experience in industry and/or at regulatory authorities and/or contract research organizations in the field of international regulatory affairs. You have excellent knowledge of European procedures and guidelines and preferable with those of the US. You can work within a team and coordinate your projects with other employees of Kinesis Pharma. You have experience or affinity for business development and are capable of building good relationships with our clients.

We are looking for a candidate with a science driven mind-set combined with the ability to provide solutions from detailed understanding and interpretation. Valued personal attributes include the ability to operate independently in an organized fashion with irreproachable professional conduct. Excellent multilingual communication skills are highly valued (Dutch and English language proficiency is essential).

An offer of employment will include a permanent contract with excellent primary and secondary terms of employment, the option of part-time employment and flexible working practices. In our organization employees can acquire a high level of responsibility and independence, benefit from the unparalleled breadth of exposure and frequent interaction with our group of experts which will broaden your knowledge, experience and expertise.

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 regular mail to: P. IJzelman, Kinesis Pharma BV, Lage Mosten 29, 4822 NK Breda, The Netherlands.