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- Contributing with regulatory expertise to global strategies and tactics
- Driving the planning and preparation of regulatory documentation – such as briefing packages for health authority meetings, global clinical trial applications, protocols and reports, paediatric development plans, and labelling
- Supporting the planning and conduct of regulatory interactions with Health Authorities worldwide regarding clinical trial activities, scientific advice, regulatory submissions and approvals
- Working with regulatory colleagues, project management, medical and non-medical specialists, statisticians, and medical writers, providing regulatory input and contributing to project decisions
- Being actively involved in establishing internal positions on regulatory issues, new and changing guidelines, and improvement projects across Regulatory Affairs
- Master's degree within Life Science, Health Science, or a related field
- Several years of regulatory experience in similar position, from the pharmaceutical industry or Health Authority
- Experience working on clinical drug development projects
- Track record or keen interest in Diabetes or related therapeutic areas
- Strong IT/digital skills
- Fluency in written and spoken English
RA Professional for clinical development projects - Søborg, Danmark - Novo Nordisk
Beskrivelse
(Senior) RA Professional for clinical development projects
Do you want to play a key role in accelerating the development of our patient-focused products? Are you passionate about regulatory science and executing on regulatory strategies to bring innovative medicines to patients?
If so, we at Novo Nordisk invite you to become a part of our dynamic and forward-looking regulatory organisation. We are expanding our team of highly engaged professionals who play pivotal roles in developing medical solutions - within diabetes and related indications - and obtaining authorisations from regulatory authorities worldwide.
The position
As a (Senior) Regulatory Affairs Professional, you will support the development of regulatory strategies and execute various regulatory tasks within cross-functional project teams. This will involve interacting with a diverse array of stakeholders throughout the process.
You will collaborate closely with the Global Regulatory Lead and a team of regulatory professionals, working together towards approvals of clinical trials and marketing authorisations. You will be an integral member of cross-functional project teams, including study groups and submission teams.
Key responsibilities will be focused on:
You will report to the manager of RA Diabetes I and take active part in department related activities.
Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office in Denmark and on-site office-based work in Søborg, Denmark where our team is based.
Qualifications
We expect an ideal candidate to have the following:
Personally, you thrive in dynamic team environments and actively contribute to the team's success. You should be well-organised, possess robust problem-solving capabilities, and maintain a strategic focus. A positive can-do attitude is crucial, as is the ability to keep your spirits high and maintain a healthy sense of humour under pressure. Effective communication skills that enable cooperation at all organisational levels are highly valued.
About the department
RA Diabetes is responsible for the development of global regulatory strategies to advance projects within diabetes 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 an area with 20 dedicated and highly engaged regulatory leads and professionals organised in 2 teams.
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 the manager Peter Brun Flarup at
Deadline
18 August 2024.
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.