Regulatory Affairs Specialist, Late-Stage Development
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Søborg
Are you thrilled about the prospect of bringing best-in-class and life-changing solutions to millions of patients? Do you dream about job with a significant, influential, and pivotal role in developing robust regulatory strategies for obtaining and maintaining our regulatory licenses?
Then we have what you have been looking for in Regulatory Affairs CMC (Chemical, Manufacture and Control), Diabetes & Obesity. Apply now for our new Regulatory Affairs Specialist role!
The Position
We are looking for a colleague with a strong scientific and technical mindset, as well as a thorough understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytics, and quality assurance) to work with the late-stage development and life cycle management of diabetes and obesity products in Regulatory Affairs CMC. In this role, you will be part of bringing a new product to the patients by obtaining the first marketing authorisations and continue the product roll out globally as well as product optimisation throughout life cycle management.
Your main tasks will include:
You will join a fun, supportive, and inclusive work environment that offers you the opportunity to continue your i ndividual development and connect your knowledge within pharmaceutical operations to the regulatory framework of CMC in benefit of the patients. You will work in a fast-paced environment with tight deadlines and work closely together with colleagues across time zones and cultures. We embrace a flexible workplace, with a blend of in-office and remote work.
Qualifications
As an ideal candidate, you need to have:
On a personal level, you are curious to learn, proactive, solution oriented, self-motivated and bring a positive attitude. You have a strategic mindset and the ability to set direction for your projects. Also, you need to challenge the discussions and contribute to project team decisions for the project you work with. Excellent communication skills and the ability to communicate scientifically difficult topics are important, so it is easily understood by diverse kinds of stakeholders such as Manufacturing Development, Research & Development, Commercial and the Health Authorities.
About the department
Regulatory Affairs CMC Diabetes & Obesity is part of Global Regulatory Affairs.
We are 45 colleagues working in different project teams from early phases of drug development throughout the life cycle of the marketed products worldwide. We are responsible for driving the RA CMC strategy and submission activities related to the drug of the drug-device development projects and the oral development projects.
Our work is essential to keep bringing innovative, patient-centric, and best-in-class solutions to our patients. That calls for team spirit, collaborative minds, skilled colleagues, and a great focus on knowledge-sharing. So, look forward to being surrounded by talented, cooperative, and embracing teammates in a strong and empowering culture filled with humble people.
Working at Novo Nordisk
At Novo Nordisk, we do not wait for change. We drive it. We are 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 are all working to move the needle on patient care.
Contact
For further information please contact Jeppe Engelheim Müggler (+45 30756025) or Samantha Donslund Schwab (+45 30794018).
Deadline
27 November 2022. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline.
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.
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Then we have what you have been looking for in Regulatory Affairs CMC (Chemical, Manufacture and Control), Diabetes & Obesity. Apply now for our new Regulatory Affairs Specialist role!
The Position
We are looking for a colleague with a strong scientific and technical mindset, as well as a thorough understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytics, and quality assurance) to work with the late-stage development and life cycle management of diabetes and obesity products in Regulatory Affairs CMC. In this role, you will be part of bringing a new product to the patients by obtaining the first marketing authorisations and continue the product roll out globally as well as product optimisation throughout life cycle management.
Your main tasks will include:
- Providing scientific and strategic input to the projects you work with to obtain the regulatory approvals
- Turning your knowledge within pharmaceutical operations into regulatory pathways and develop global regulatory CMC strategies based on current legislation and regulations
- Planning, coordinating, and reviewing regulatory documentation related to the drug (supporting preparation of applicable sections of submission packages, responses to agency questions for global markets and Agency Meeting Packages)
You will join a fun, supportive, and inclusive work environment that offers you the opportunity to continue your i ndividual development and connect your knowledge within pharmaceutical operations to the regulatory framework of CMC in benefit of the patients. You will work in a fast-paced environment with tight deadlines and work closely together with colleagues across time zones and cultures. We embrace a flexible workplace, with a blend of in-office and remote work.
Qualifications
As an ideal candidate, you need to have:
- M.Sc . or Ph.D. in science, pharmaceutical science, engineering, or another relevant academic field
- +5 years of experience working in pharmaceutical operations (e.g., manufacturing, process development, analytics, and quality assurance)
- Experience with Regulatory Affairs and/or project management will be an advantage but not a requirement
- Fluent written and spoken English
On a personal level, you are curious to learn, proactive, solution oriented, self-motivated and bring a positive attitude. You have a strategic mindset and the ability to set direction for your projects. Also, you need to challenge the discussions and contribute to project team decisions for the project you work with. Excellent communication skills and the ability to communicate scientifically difficult topics are important, so it is easily understood by diverse kinds of stakeholders such as Manufacturing Development, Research & Development, Commercial and the Health Authorities.
About the department
Regulatory Affairs CMC Diabetes & Obesity is part of Global Regulatory Affairs.
We are 45 colleagues working in different project teams from early phases of drug development throughout the life cycle of the marketed products worldwide. We are responsible for driving the RA CMC strategy and submission activities related to the drug of the drug-device development projects and the oral development projects.
Our work is essential to keep bringing innovative, patient-centric, and best-in-class solutions to our patients. That calls for team spirit, collaborative minds, skilled colleagues, and a great focus on knowledge-sharing. So, look forward to being surrounded by talented, cooperative, and embracing teammates in a strong and empowering culture filled with humble people.
Working at Novo Nordisk
At Novo Nordisk, we do not wait for change. We drive it. We are 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 are all working to move the needle on patient care.
Contact
For further information please contact Jeppe Engelheim Müggler (+45 30756025) or Samantha Donslund Schwab (+45 30794018).
Deadline
27 November 2022. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline.
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.
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 8.11.2022, 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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