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In a fast growing Biotech Company
Ascendis Pharma is in the process of expanding its pipeline with more drug candidates and is putting considerable emphasis on the further clinical development of its own products. A late stage project is also moving towards marketing registration and commercialization, and they are now looking for a Director, Regulatory Affairs with focus on devices.
As Director, Regulatory Affairs (Device) at Ascendis Pharma you will be a key member of the Regulatory Affairs team and provide effective support to the organization to ensure the best development programs for your designated projects. You will be responsible for strategic and operational regulatory oversight for devices worldwide, including drug/biologic/device combination products, in collaboration with the rest of the RA and technical teams. It is a once in a lifetime opportunity to be part of setting up the structure and function of Regulatory Affairs regarding device related activities. The position does not contain managerial responsibility.
With direct report to Senior Director, Regulatory Affairs.
Your main tasks are:
Your qualifications include a proven record of accomplishment and at least 8-10 years of documented professional experience from a Regulatory Affairs device position from a pharmaceutical/biotechnology company preferably working with injection devices/combination products. Further, you have experience with regulatory device lifecycle management and interactions with Health Authorities and knowledge of international legislation and standards.
You have a Master’s Degree within Natural Science or a related field but most important, extensive regulatory device experience working with regulations of medical devices. In addition, you have excellent verbal and written skills and are able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders.
You are a person who thrives on being challenged and working in collaborative environments. Strong interpersonal skills are necessary, as you will serve as a major contributor and trusted member of the project development teams. A proven ability to communicate with other development staff in a fast-paced environment is crucial. Finally, an ability to think and manage strategically with attention to detail is needed, as is a high energy level, focus, and a passion and sense of urgency for developing important new medicines for devastating diseases.
Ascendis Pharma offers you an exciting and challenging position in an entrepreneurial and international company with a short line of command. You will be involved in activities that are central to Ascendis Pharma’s strategy and work with highly skilled and experienced colleagues to advance their exciting product pipeline and get the first product on the market.
Travelling: 15-20 days per year.
Domicile: Ascendis Pharma resides in a wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals and the sea.
For more details about the job or the company, please contact Research Consultant, Jeanne Dederding, Unique Human Capital on M: +45 28 74 58 71. All applications must be in English and are treated confidentially.