Senior Regulatory Affairs Associate

SciPro have exclusively partnered with an innovative pharmaceutical company who are driven by their purpose to reimagine how drugs can improve the quality of life of patients with rare disease. They are a fast growing, agile organization transforming the lives of patients and care givers through the use of cutting-edge pharmaceutical technologies to translate pioneering science to medicine products.

We are supporting them on their search for a Senior Regulatory Affairs Associate to lead compliant product labelling and artwork of their product portfolio. You will join the Regulatory Affairs team in the UK and have the chance to make a real impact on multiple projects to support the company growth and ultimately, make a difference to the patients the company support.

Key Responsibilities:

• Lead U.S. labelling and artwork activities
• Lead the preparation of ANDA/NDA submissions
• Lead promotional material submissions to the FDA

Key Requirements:

• 4+ years of regulatory affairs experience
• Experience with Adobe Illustrator or Adobe InDesign
• Prior experience with US FDA regulations