Associate Director, Device Regulatory Affairs
Are you experienced within device regulatory affairs and are you passionate about finding new pathways for approval of combination products? Then this might be an interesting job for you
Ascendis Pharmais a fast-growing, dynamic biopharmaceutical company with Headquarters in Hellerup, Denmark that offers you room to grow and the freedom to take responsibility and make a difference for patients every day.As our new Associate Director RA Device, you will be driving the regulatory strategy for device constituent parts of combination products and use your device regulatory experience to provide regulatory guidance to development projects. As a member of our global team of 4 colleagues, you will work with highly skilled and passionate colleagues to advance our exciting product pipeline.
You will be responsible for:
Regulatory plan for device: You will proactively develop regulatory strategies for development of device constituent parts thereby supporting submission of drug device combination products globally. You will collaborate with RA colleagues and cross functional peers to facilitate the product approvals and registration process.
Regulatory submissions: You will drive the regulatory communications with health authorities on the device constituent part of product applications on assigned development projects. In this job you will also have the opportunity to drive new processes, e.g. for devices used in clinical trials.
Regulatory intelligence and policies: You will contribute to establishing and administering internal regulatory policies and procedures to achieve best practices work processes. Stay abreast of newly issued regulatory laws and guidance to promptly identify possible impact or improvement to devices in the programs. You are expected to actively participate in professional and industry organizations to follow regulatory trends.
Your professional qualifications
To enter this position, you have a minimum 6 years of documented professional experience from a Regulatory Affairs position from a pharmaceutical/biotechnology company developing device constituent parts of combination products. Experience with devices and , in-vitro diagnostics is also relevant for this position. You must have extensive regulatory experience with clinical applications, e.g. IDE/IND/CTA and with submission of NBOp and NDA/BLA/MAA’s. Finally, you have demonstrated an ability to collaborate effectively with multiple functions, including Research, Device & CMC Development, Clinical, Commercial, and Quality.
You hold a relevant Master’s degree within Life Science and you have experience working as a RA project member of BLA and/or NDA filings. Furthermore, you have a strong understanding of device development and combination products and how to present data to Notified Bodies and FDA. You are proficient in English at a professional level, both written and spoken.
As a person, you thrive in being challenged and working in collaborative environments. Strong interpersonal skills are necessary, as you will collaborate with many different stakeholders in the projects. In addition, 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.
Travel: 10 days per year.
Place of work: Ascendis Pharma headquarter resides in a modern and wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals, and the sea.
Applications will be evaluated when received, so please apply as soon as possible.