Regulatory Officer
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Ørestad
Are you highly motivated by being able to make a difference to improving patients’ lives? Are you a high performing person, who gets energized by challenges and is able to motivate people around you? The position of Regulatory Affairs Officer will give you the opportunity to work in a high performing team, to contribute directly towards the business results, while creating values for patients. Interested? If so, continue reading and apply today!
The Position
You will ensure products can be placed on the market with optimal yet compliant claims, advertising, and promotion in line with commercial plans. You’ll also ensure products are maintained and meet internal and external compliance requirements, be a productive part of defined local regulatory team, including being a proactive partner to other stakeholders. You will also engage with the external regulatory environment within defined area of accountability, and act as the voice of Novo Nordisk. The role will also work together with regulatory colleagues in Iceland, outside vendors, and other stakeholders to proactively look for opportunities and solutions to challenges. Your main responsibilities will be:
Qualifications
You will be successful if:
About the Department
You will join a small team made by passionate people that strives for excellence. In our team we are ongoing looking at our processes and how we can work smarter though still living up to obligations and legal requirements. We are also a very flexible team when it comes to work and private life. As long as we keep our timelines, and we all share the workload. We take pride in being the licence to operate and we have the finger on the pulse based on having the direct contact to the customers. You will report directly to the Head of Regulatory Safety and Customer Service.
Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.
Contact
Please apply through our system if you’re interested and we will review your application promptly. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
Deadline
Apply before 17.11.2020
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.
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The Position
You will ensure products can be placed on the market with optimal yet compliant claims, advertising, and promotion in line with commercial plans. You’ll also ensure products are maintained and meet internal and external compliance requirements, be a productive part of defined local regulatory team, including being a proactive partner to other stakeholders. You will also engage with the external regulatory environment within defined area of accountability, and act as the voice of Novo Nordisk. The role will also work together with regulatory colleagues in Iceland, outside vendors, and other stakeholders to proactively look for opportunities and solutions to challenges. Your main responsibilities will be:
- To take charge of Life Cycle Management of marketed products in Denmark, from . updating product information, packeting material and introducing new products to the Danish market.
- To lead the development of strategies and plans to mitigate, so that we can deliver products backed by science, that are robust and aligned with business needs.
- To actively contribute to high performing teams, including looking for ways to improve performance, build relationships with key stakeholders and represent Novo Nordisk in a responsible manner, according to company values. Also, to communicate Novo Nordisk’s policies and strategies, and negotiate outcomes, as well as manage compliance within defined portfolio/activity streams in line with Novo Nordisk.
- To contact and liaise with authorities such as the Danish Medicines Agency.
- To proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business and understanding of RA structure & local regulations.
Qualifications
You will be successful if:
- You have a background in healthcare or in the life sciences and preferably 2 years of work experience with regulatory submissions/approvals.
- You have been involved in promotional review in all or some aspects of the full life cycle of submissions.
- You have great time management skills, are an analytical thinker, can handle several tasks at the same time, and have an eye for relevant detail.
- You are tech savvy; you can handle complex IT systems as part of your daily work.
- You are fluent in Danish and English and are persuasive and impactful.
About the Department
You will join a small team made by passionate people that strives for excellence. In our team we are ongoing looking at our processes and how we can work smarter though still living up to obligations and legal requirements. We are also a very flexible team when it comes to work and private life. As long as we keep our timelines, and we all share the workload. We take pride in being the licence to operate and we have the finger on the pulse based on having the direct contact to the customers. You will report directly to the Head of Regulatory Safety and Customer Service.
Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.
Contact
Please apply through our system if you’re interested and we will review your application promptly. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
Deadline
Apply before 17.11.2020
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.
Print job Send to e-mail
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Ørestad.
Jobbet er oprettet på vores service den 26.10.2022, 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
- Ørestad
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