Regulatory Specialist

The position

In this role, you will report to the Senior Director of RA Diabetes and Obesity and take active part in department related activities, including improvement projects across Regulatory Affairs. Your key responsibilities will include the following: Drive and coordinate several regulatory activities with challenging and often overlapping timelines Provide strategic input and regulatory expertise to the project development plan and organisation, and will evaluate project risks and recommend regulatory mitigations Interact with internal and external stakeholders, and be a member of cross functional project teams Ensure regulatory deliverables successfully meet project and business objectives while adhering to regulatory requirements and guidance within drug development Assume the role of the challenger who makes an impact, seeks solutions, and drives innovation Qualifications We expect you to have: University degree in Life Science or similar 8+ years of Regulatory Affairs experience within late-stage development and/or early life-cycle management Solid experience with defining and developing global regulatory strategies and good all-around understanding of the regulatory documentation and requirements for pharmaceutical development and licensing Experience interacting directly with regulatory authorities on an international scale Fluent written and spoken English As a person, you are a team player and collaborator, well organised and have solid problem-solving capabilities, just as you show a can-do attitude and never lose your strategic focus. You can keep your spirits high even when under pressure. You are a skilled communicator who can collaborate at any organisational level. About the department The Regulatory Affairs Diabetes & Obesity team develops global regulatory strategies for multiple indications, from early development to worldwide submissions and approvals of initial Marketing Authorisation applications. As an integral part of the global development organisation, we play a key role in cross-functional teams. Our responsibilities include developing, implementing, and executing global regulatory strategies aligned with the project development plan, driving label development, health authority interactions, and regulatory submissions, as well as collaborating closely with affiliates and global stakeholders. Regulatory Affairs Diabetes & Obesity currently consists of 17 dedicated and highly engaged employees. The team is expanding as the project progress into multiple indications, late-stage development and submission, and thus we are looking for a new colleague with a strong scientific background combined with regulatory affairs experience to be part of the RA team for one of our high priority late-stage development projects. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.