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Regulatory Specialist/Global Regulatory Lead - RA GLP-1 and NASH Projects

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 GLP-1 and NASH Projects are responsible for marketed development Injectable GLP-1 products within diabetes treatment and or development projects for with Non-alcoholic steatohepatitis (NASH). 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 Regulatory Specialist with a scientific background combined with extensive regulatory and drug development experience to take on the role as Global Regulatory Lead (GRL) for diabetes or NASH in early or late phase of development and be responsible for the global regulatory strategy.

 

The job
As Regulatory Specialist/GRL 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 core teams/global project teams. Here, you ensure regulatory deliverables according to agreed timelines, cost and quality. You will assume the role of the challenger who makes an impact, creates solutions and drives innovations.

 

Furthermore, you will lead global regulatory teams being responsible for regulatory activities for diabetes or NASH projects. As a Regulatory Specialist/GRL, you will be overall 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 medical specialists, commercial colleagues, 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.

 

Dependent of your experience and background the area of responsibilities will be determined. You will report to the Director of RA GLP-1 and NASH 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 which may be complemented by a PhD and have many years of regulatory and drug development experience. From your career you have solid experience of handling regulatory documentation for pharmaceutical development within the quality, non-clinical and clinical area. You have experience interacting directly with regulatory authorities on an international scale. You have proven strong negotiation skills and a sound business understanding. You also know how to set direction, lead and motivate your team to work for joint objectives. At the same time, you are the team player who assists your colleagues.

 

As a person you are well organised and have solid problem-solving capabilities, just as you show a winning attitude and a strategic focus. You can keep your spirits high even when under pressure. You are a skilled communicator and project manager who can collaborate at any organisational level. Finally, you are comfortable using your fluent written and spoken English in your daily work.

 

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 workplace, where passion and engagement are met with opportunities for professional and personal development.

 

Contact
For further information, please contact David Truloff +45 30 79 04 99

 

Deadline

22 Nov 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 chronic 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.


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