Senior Regulatory Professional/Global Regulatory Lead - RA Oral Peptide & CVD Projects
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Søborg
- Regulatory
- Søborg
Join Regulatory Affairs (RA) and become part of an exciting environment where engaged people are committed gaining approval of Novo Nordisk’s medicines by regulatory authorities across the globe. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work.
About the department
RA Oral Peptide & Cardiovascular Disease (CVD) Projects are responsible for development projects within the innovative new delivery technology that brings peptides in tablets available to patients or development projects for cardiovascular diseases. We are eleven dedicated and highly engaged employees working in the department.
We work as an integrated part of the global development and research project teams and cross-functional sub-teams. We are responsible for the regulatory strategy and provide regulatory expertise and tactics to the product development plan. We drive label development, Health Authority interactions and clinical trial applications. We have a strong collaboration with our affiliates and work in global regulatory teams.
We are currently looking for a new colleague with a strong scientific background who has a genuine interest in being part of the future of new technologies that can bring innovative medicines to patients worldwide.
The job
As a Senior Regulatory Professional you will take on the role as Global Regulatory Lead for projects in early phase of development and be responsible for Life Cycle Management activities for a marketed product.
You will be responsible for the project plan and project execution, provide regulatory input for the project strategy, interact with internal and external stakeholders (e.g. Health Authorities) and represent Regulatory Affairs in project teams.
Furthermore, you will be responsible for submission and approval of clinical trial applications, for driving and coordinating preparation of meeting packages to Health Authorities, conduct Health Authority interactions and for regulatory submissions and approvals. You will interact with marketing and medical specialists, researchers and regulators. All in all, you will have a large responsibility and you will have a lot of influence and impact on the way we reach our goals.
You will report to the Senior Director of RA Oral Peptide & CVD Projects and take active part in department related activities, including improvement projects across RA.
Qualifications
We expect you to have a university degree in life science preferably complemented by a PhD and have 5-7 years of regulatory and drug development experience.
As a person you thrive in a busy environment; bring can-do spirit and a healthy sense of humor to your work – even when the pressure is on. You are a flexible and change-oriented person who focuses on opportunities rather than limitations in challenging situations. You are a skilled communicator who can cooperate at any organizational level. Finally, you are comfortable using your fluent written and spoken English on a daily basis.
Working at Novo Nordisk
At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.
Contact
For further information, please contact Vibeke Hatorp at +45 3075 5697.
Deadline
23. August 2020.
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 9.7.2020, 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.
- Afdelingsleder
- Søborg
- Søndag den 23. august 2020
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