Regulatory Affairs Manager

Job description: You will provide strategic and operational regulatory support in project development teams and liaise proactively with expert functions and consultants. You will join a team of 4 people and report to Head of Regulatory Affairs. You will be involved in a broad range of regulatory affairs issues and tasks and build excellent regulatory competence within Orexo. Personal characteristics: You are a self-starter and enjoy taking initiative. You are a team player and possess integrity, a sense of responsibility, commitment and loyalty. You maintain a positive attitude and have a natural ability to enthuse others. Energetic and creative are also adjectives that describe you. Requirements: A degree in life sciences is preferred. Several years experience in drug development and Regulatory Affairs from the pharmaceutical industry or Contract Resource Group (CRO). Good knowledge of US and EU requirements. Good understanding of the business environment and the ability to identify and assess business risks for a given regulatory strategy. Results-oriented and able to multi-task. Excellent communication skills. Fluent written and spoken English. --------------------------------------------------------------------------------------- Orexo is a pharmaceutical company that focuses on developing new pharmaceutical drugs within areas currently subject to considerable clinical needs. Orexo s products are based on existing pharmaceuticals and the company s patented drug-delivery technologies. Orexo applies its broad expertise in medicine and pharmacy to the further development of existing pharmaceutical substances. By combining well-documented compounds with its own patented drug-delivery methods and its unique expertise in "dry formulations" (for example, tablets), Orexo is able to develop new patented pharmaceuticals. At present, the company has two products on the market, one product submitted for registration on the European market, three in late stage clinical development - one of which has been out-licensed in the US, Europe and Japan - and two projects in pharmaceutical formulation phase. Orexo has an active intellectual property rights strategy and an extensive patent portfolio to protect its products and technologies. Orexo is listed on the OMX Nordic List Mid Cap (ticker: ORX). www.orexo.com --------------------------------------------------------------------------------------