Regulatory Affairs Specialist
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Søborg
Do you want to be part of shaping the future for the Novo Nordisk pipeline? If so, the job as Regulatory Affairs Specialist in Regulatory Affairs (RA) Chemistry Manufacturing Control (CMC), Diabetes & Obesity is just what you are looking for! Join a fast-changing environment where engaged people do their best every day, to obtain and maintain clinical trial applications and market authorisations worldwide, for all Novo Nordisk medicinal products across the globe. Apply to be part of a life-changing career! The position
As a specialist in RA CMC Diabetes & Obesity, you are expected to demonstrate leadership by setting regulatory strategic direction for the high impact projects you work on. The strategies are developed in accordance with CMC development activities, and it is necessary to be able to turn scientific progress into regulatory pathways. In addition, your main responsibilities will include:
• Guide and mentor junior colleagues.
• Participate in cross functional forums.
• Contribute to improvements projects enabling us to stay one step ahead. You will work in a fast-paced environment and work closely together with colleagues across time zones and cultures. You will work from our office in Søborg, Denmark or remotely. The atmosphere is informal and good humour is always welcome. This is an opportunity for you to continue your individual development and stay updated within relevant regulatory and biotech disciplines and you can expect to build an extensive internal network. Qualifications
To be a great asset to our team you will have:
• A MSc degree and/or PhD such as Biochemistry, Pharmaceutical Science or similar.
• Extensive experience from the pharmaceutical industry or from a medical agency.
• Previous experience in regulatory CMC.
• A strong scientific and technical mindset, as well as a thorough understanding of related pharmaceutical operations.
• Ability to communicate science related topics with Health Authorities. On a personal level you are curious to learn, well organised and a proactive problem solver, and enjoy working in a team in a project-oriented organisation. Your positive attitude will be valued in this changing environment. As a proactive person, you can focus on jointly moving the projects and can work independently, bringing an innovative mindset seeking novel solutions to the challenges we face.
About the department
RA CMC Diabetes & Obesity is an area in Development where 50 colleagues are working in a matrix set-up with the purpose of obtaining and maintaining clinical trial applications and market authorisations worldwide for Novo Nordisk new Diabetes and Obesity products across the globe including both the injectable and increasing oral pipeline. We strive to develop and implement innovative regulatory strategies based on current legislation and regulations so that we together with our stakeholders from e.g., Product Supply, CMC, Clinical RA areas, RA affiliates and Marketing can make future Novo Nordisk medicines available to patients. 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 necessary 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 Samantha Donslund Schwab (+45 3079 4018) or Jeppe Engelheim Müggler (+45 3075 6025).
Deadline
11 June 2023 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.
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.
As a specialist in RA CMC Diabetes & Obesity, you are expected to demonstrate leadership by setting regulatory strategic direction for the high impact projects you work on. The strategies are developed in accordance with CMC development activities, and it is necessary to be able to turn scientific progress into regulatory pathways. In addition, your main responsibilities will include:
• Guide and mentor junior colleagues.
• Participate in cross functional forums.
• Contribute to improvements projects enabling us to stay one step ahead. You will work in a fast-paced environment and work closely together with colleagues across time zones and cultures. You will work from our office in Søborg, Denmark or remotely. The atmosphere is informal and good humour is always welcome. This is an opportunity for you to continue your individual development and stay updated within relevant regulatory and biotech disciplines and you can expect to build an extensive internal network. Qualifications
To be a great asset to our team you will have:
• A MSc degree and/or PhD such as Biochemistry, Pharmaceutical Science or similar.
• Extensive experience from the pharmaceutical industry or from a medical agency.
• Previous experience in regulatory CMC.
• A strong scientific and technical mindset, as well as a thorough understanding of related pharmaceutical operations.
• Ability to communicate science related topics with Health Authorities. On a personal level you are curious to learn, well organised and a proactive problem solver, and enjoy working in a team in a project-oriented organisation. Your positive attitude will be valued in this changing environment. As a proactive person, you can focus on jointly moving the projects and can work independently, bringing an innovative mindset seeking novel solutions to the challenges we face.
About the department
RA CMC Diabetes & Obesity is an area in Development where 50 colleagues are working in a matrix set-up with the purpose of obtaining and maintaining clinical trial applications and market authorisations worldwide for Novo Nordisk new Diabetes and Obesity products across the globe including both the injectable and increasing oral pipeline. We strive to develop and implement innovative regulatory strategies based on current legislation and regulations so that we together with our stakeholders from e.g., Product Supply, CMC, Clinical RA areas, RA affiliates and Marketing can make future Novo Nordisk medicines available to patients. 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 necessary 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 Samantha Donslund Schwab (+45 3079 4018) or Jeppe Engelheim Müggler (+45 3075 6025).
Deadline
11 June 2023 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.
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 23.5.2023, 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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