Regulatory Specialist
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Søborg
Join Global Regulatory Affairs (RA) and become part of a dynamic and exciting organisation where engaged people are committed to obtain Marketing Authorisations for Novo Nordisk’s innovative medicines by regulatory authorities across the globe. We have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work. Apply now for this life-changing opportunity and join us as Regulatory Specialist! The position In this role, you will report to the Senior Director of RA Cagrisema 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. Contact For further information, please contact Eva Thomsen at +45 3075 0253. Deadline 10 April 2023. Please note we will invite candidates for interviews on an ongoing basis and conclude the recruitment process when the right candidate has been found. You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. Please assist us in maintaining a fair and inclusive selection process by not attaching a photo to your application. 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 14.3.2023, 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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| Dato | Alle jobs som øvrige |
|---|---|
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| 6. april 2024 | 71 |