Regulatory Professionals in department Regulatory Affiliate Support
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Søborg
We are expanding our product and project pipeline in Novo Nordisk and are looking for engaged Regulatory Professionals to join Regulatory Affiliate Support within the area of Regulatory Affairs CMC (Chemistry, Manufacturing and Controls) & Devices. If you are curious about working across Novo Nordisk product portfolio, willing to drive, coordinate, and to work globally with colleagues from different backgrounds and cultures, this might be the job you are looking for.
The position
As a Regulatory Professional you will be the centre of planning, coordination, and execution of additional registration file documentation such as export certificates and statements as well as product samples critical for submissions to health authorities worldwide. To obtain fast submissions and regulatory approvals you are expected to assess regulatory requirements and local regulations and provide solutions accordingly. You will act as central point of contact for affiliates and be involved in submissions across Novo Nordisk portfolio; these at various stages and with overlapping and often challenging timelines.
You will work in a fast-paced environment and the role requires the ability to work effectively with people across the organisation, calling for high cultural awareness and the necessary skills to take the lead, encourage and influence. You are expected to bring forward regulatory insight, be proactive and take actively part in discussions and interactions.
Qualifications
To succeed in this role, we expect you to have:
As a person you bring a can-do spirit and a healthy sense of humour to work. You are a flexible and change-oriented person who likes to experiment and sees opportunities rather than limitations in challenging situations. It is imperative that you are well organized, can handle tight deadlines, and manage multiple assignments without losing track. You possess strong analytical skills and problem-solving capabilities and address your responsibilities with decisiveness and a positive mind-set.
About the department
In Regulatory Affiliate Support, we are responsible for the additional regulatory documents process supporting submissions worldwide and across Novo Nordisk product portfolio. We are 12 dedicated and highly engaged employees in the department with diverse background and experience. We have a strong collaboration with our stakeholders across the organisation both within headquarters as well as affiliates. In Regulatory Affiliate Support we seek continuously to improve our processes to support fast submissions and approvals, and to ensure compliance with the global regulatory landscape which is constantly changing. We have an informal environment where a good sense of humour is welcome.
Working at Novo Nordisk
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.
Contact
For further information, please contact Tina Lindquist at +45 3075 9652.
Deadline
06 December 2022.
Applications will be reviewed continuously, and we will conduct interviews on an ongoing basis, so please submit your application as soon as possible.
Please submit your CV as well as a cover letter.
To ensure an efficient and fair recruitment process, please refrain from adding a photo in 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.
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The position
As a Regulatory Professional you will be the centre of planning, coordination, and execution of additional registration file documentation such as export certificates and statements as well as product samples critical for submissions to health authorities worldwide. To obtain fast submissions and regulatory approvals you are expected to assess regulatory requirements and local regulations and provide solutions accordingly. You will act as central point of contact for affiliates and be involved in submissions across Novo Nordisk portfolio; these at various stages and with overlapping and often challenging timelines.
You will work in a fast-paced environment and the role requires the ability to work effectively with people across the organisation, calling for high cultural awareness and the necessary skills to take the lead, encourage and influence. You are expected to bring forward regulatory insight, be proactive and take actively part in discussions and interactions.
Qualifications
To succeed in this role, we expect you to have:
- A master’s degree in a relevant field such as life or health science, pharmacy, or business, and preferably 3-4 years of experience from the pharmaceutical industry
- Excellent communication skills and are comfortable and competent to communicate in both verbal and written English
- Business and process orientation
- Flair for IT systems
As a person you bring a can-do spirit and a healthy sense of humour to work. You are a flexible and change-oriented person who likes to experiment and sees opportunities rather than limitations in challenging situations. It is imperative that you are well organized, can handle tight deadlines, and manage multiple assignments without losing track. You possess strong analytical skills and problem-solving capabilities and address your responsibilities with decisiveness and a positive mind-set.
About the department
In Regulatory Affiliate Support, we are responsible for the additional regulatory documents process supporting submissions worldwide and across Novo Nordisk product portfolio. We are 12 dedicated and highly engaged employees in the department with diverse background and experience. We have a strong collaboration with our stakeholders across the organisation both within headquarters as well as affiliates. In Regulatory Affiliate Support we seek continuously to improve our processes to support fast submissions and approvals, and to ensure compliance with the global regulatory landscape which is constantly changing. We have an informal environment where a good sense of humour is welcome.
Working at Novo Nordisk
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.
Contact
For further information, please contact Tina Lindquist at +45 3075 9652.
Deadline
06 December 2022.
Applications will be reviewed continuously, and we will conduct interviews on an ongoing basis, so please submit your application as soon as possible.
Please submit your CV as well as a cover letter.
To ensure an efficient and fair recruitment process, please refrain from adding a photo in 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.
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 Søborg.
Jobbet er oprettet på vores service den 2.11.2022, 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
- Søborg
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