Regulatory Affairs Manager, Janssen

An exciting opportunity has arisen to join the EMEA Regulatory Affairs Established Products Therapeutic Area team at Janssen. This position as a Regulatory Affairs Manager, Expert on Value Optimizers, includes the responsibility for a range of Established Products as well as activities within the Regulatory Affairs function. You are part of a European organization, meanwhile dedicated to the Nordic local operating company. The position reports to the Team Leader of Regulatory Affairs Expert on Value Optimizers. The position can be located preferably in Norway, but also in Finland or Denmark. It is an office-based position with limited traveling. Objectives of the Position Keep an overview of all regulatory-related activities for the assigned products, such as supervising the implementation of procedures and compliance. Operational contacts with local Health Authorities. Perform all required product tasks, following plan and updates from Regulatory head office, enabling efficient label implementation and maintenance. Ensure that, where any local issues are identified as potentially impacting regulatory strategy, these are highlighted to management to ensure that the regulatory strategy can be implemented efficiently. Ensure efficient compliance to local, regional, and Janssen regulations, to minimize risk for the patients and Janssen business. Represent Regulatory Affairs in Nordic cross-functional Value Teams for Established Products. What you will need to succeed We are looking for a multifaceted and result-oriented professional willing to work hard and devote time, energy, and dedication to the work. You work independently in a virtual environment with the capability to work under your own initiative, self-starting and proactive, while at the same time being an excellent teammate in collaborations. You are flexible, have a