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Senior Regulatory Professional - Global Regulatory Lead

Novo Nordisk A/S



Category: Regulatory Location: Søborg, Capital Region of Denmark, DK

Do you have a strong scientific background? Are you motivated by driving projects with a global impact? And do you want to be part of a team of engaged people doing their best every day to get Novo Nordisk’s medicines approved across the globe?

Then join ‘Regulatory Affairs’ as our new Senior Regulatory Professional within Haemophilia projects.

About the department
RA Haemophilia is responsible for the regulatory deliverables for clinical projects as well as life cycle managements of approved products.

We are responsible for the regulatory strategies and provide regulatory expertise and tactics to the product development plan. We drive label development, Health Authority interactions, clinical trial applications and global submission strategies. We have a strong collaboration with our affiliates and work in global regulatory teams.

In RA Haemophilia we are 14 dedicated and highly engaged employees. Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. We work as an integrated part of the global development and research project teams and cross-functional sub-teams.

All of this makes Regulatory Affairs a truly interesting place to work in a fast-changing environment.

The job
As a Senior Regulatory Professional - Global Regulatory Lead, you will be the overall product responsible and responsible for driving several regulatory tasks with a high degree of complexity. You will be a member of cross functional project teams including study groups and submission teams, and as such, interact with a variety of stakeholders from different departments in Novo Nordisk.

You will be responsible for the development of regulatory documentation for submission to Health Authorities, including regulatory file for authorisations globally, responses to questions from Health Authorities, briefing packages for meetings with Health Authorities, clinical trial applications, clinical trial protocols and reports etc.

Furthermore, you will contribute to the global regulatory strategies and tactics, project team decisions, improvement and maintenance of regulatory processes across the organisation.

Qualifications
We expect you to have a Master’s degree in Science and minimum 5-7 years of experience from working in Regulatory Affairs within Pharma.

You have a thorough understanding of regulatory requirements and guidelines and you have experience from working with clinical regulatory activities in development projects.

Preferably you have experience from preparation and submission of a BLA/MAA globally. Experience with rare diseases is an advantage.

You have a flair for IT systems and experience with MS Office applications. Fluency in written and spoken English is a must.

On a personal level, you have good communication, project management and negotiation skills as you will interact with project management, medical and non-clinical specialists, trial managers, statisticians and medical writers.

You combine your ability to understand technical and operational challenges with a strategic mindset. You work according to high ethical standards, a strong quality mind-set and with the patient in mind.

Contact
For further information, please call Jane Møll Pedersen at +45 30753759 until 03 July 2020

Deadline
27 July 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.

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.

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Ansøgningsfrist d. 27.07.2020
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Novo Nordisk A/S - hurtigt overblik


Novo Nordisk A/S
Novo Nordisk A/S
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity.

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Logo: Novo Nordisk A/S
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