Senior Global Regulatory Lead
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Søborg
J oin our esteemed Regulatory Affairs (RA) area as a Senior Global Regulatory Lead and contribute to an exhilarating and dynamic organisation. At our company, we are dedicated to obtaining Marketing Authorisations for i nnovative medicines from regulatory authorities worldwide. If you possess the capability to take charge and spearhead regulatory strategies for high-impact projects, while fostering collaboration with experts from diverse functions within a global setting, we invite you to be part of Novo Nordisk – a leading global healthcare company. Don't miss this opportunity and apply now! The position We have vacant positions within two therapeutic areas: “Cardiovascular & Chronic Kidney Diseases” and “Diabetes & Obesity” (please note in your CV/Cover Letter if you have a specific preference). As Senior Global Regulatory Lead, you will be overall accountable for developing regulatory strategies and executing several regulatory tasks with challenging and often overlapping timelines. You will lead regulatory matrix teams to ensure timely and high-quality regulatory deliverables to the global project teams. The role offers great breadth of responsibility, complexity, and organisational visibility, and you will have a lot of influence and impact on the project direction and decisions. Your main responsibilities include: Represent Regulatory Affairs in Global Project Team Provide strategic input and regulatory expertise to the project development plan and evaluate project risks and recommend regulatory mitigation Interact with internal and external stakeholders and represent Regulatory Affairs in regulatory matters Develop regulatory documentation for submission to Health Authorities including meeting briefing packages, clinical trial applications, paediatric plans, regulatory file for marketing authorisation and response packages for Health Authorities Qualifications As an ideal candidate, you need to have: Master’s degree or PhD in life science or similar Several years of regulatory or drug development experience in similar position, preferably from the pharmaceutical industry or Health Authority Proven track record of leadership, project management, stakeholder management and planning Hands-on experience navigating within an environment of tight timelines, high complexity, non-standards, and diverse tasks Strong IT/digital skills Advanced level of written and spoken English is required Demonstrating proactivity and employing excellent project management skills are essential to this role. You should be able to set clear direction and take the initiative to ensure tasks are completed efficiently. Additionally, you should be a team player who is willing to assist colleagues and work towards shared objectives. This means having an inclusive mindset and respecting the diversity of others. In addition to being flexible and change-oriented, you should enjoy experimenting and seeing opportunities in challenging situations. Finally, a good sense of humour and the ability to remain positive and motivated under pressure is considered an advantage. About the departments RA Diabetes and Obesity Development Projects is responsible for the development of global regulatory strategies to advance the project within multiple indications from early stages of development to worldwide submission and approvals of initial Marketing Authorisation applications in close collaboration with our affiliates and global stakeholders. This is a new area that consists of 24 dedicated and highly engaged leads and regulatory professionals organised in 3 teams. We currently have multiple active projects covering a broad area, encompassing diverse domains, and functional areas of focus. RA Cardiovascular & Chronic Kidney Disease is responsible for contributing to the development of different products and projects within the cardio-vascular and chronic kidney diseases field working with a pipeline including early and late phase projects that investigate a variety of different modalities and technologies including monoclonal antibodies and oral administered compounds. Our department is made up of 13 dedicated and highly engaged employees with diverse background and experience. 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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact For further information, please contact Poul-Martin Haahr at +45 30754082. Deadline 13 August 2023. We will review the applications on an ongoing basis, so we encourage you to apply as soon as possible. We are looking for several similar profiles at Novo Nordisk now. Therefore, Hiring Managers from different teams might also look at your application. To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 14.7.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Søborg
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