Kinesis Pharma is currently looking for a Senior Consultant RA. The Senior Consultant Regulatory Affairs will be involved in a broad range of activities of regulatory affairs for Europe and US. They will contribute to development plans and will be responsible for strategic regulatory advice. They will author and /or coordinate the writing of the scientific regulatory documentation with other departments within Kinesis Pharma or at our sponsors and coordinate outsourcing of regulatory activities to third parties if applicable. They will be responsible for communications with the regulatory authorities including meetings between the sponsor and regulatory authorities.
The successful candidate will hold 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. They will have excellent knowledge of European regulatory procedures and guidelines, affinity with, and knowledge of US regulatory guidelines and procedures is preferred. They will have team work and project management skills. They will have experience or affinity for networking and business development and be capable of building and maintaining 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).
Depending on his/her competency and experiences, the successful candidate may assume to take the lead in RA.
The position is for a minimum of 32 hours per week, with flexibility from both sides. We offer an employment with excellent primary and secondary conditions. In our organisation 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.
How to apply:
Please forward your CV (in English) and motivation letter by email to Conny van de Linde, Human Resources Manager, via email@example.com.
Your letter of application and CV may also be sent by regular mail to:
Conny van de Linde, Human Resources Manager, Kinesis Pharma BV, Lage Mosten 29, 4822 NK Breda, The Netherlands.
If you would like more information regarding this position or for a confidential discussion regarding your career please call Ron van ‘t Hof, Director CMC, via +31 6 11595280 or via e-mail ron.vantHof@kinesis-pharma.com
We do not require the services of agencies for this role.
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