Senior Regulatory Professional - biopharm

Novo Nordisk A/S

Fuldtidsjob
Storkøbenhavn

Category:

Regulatory

Location:

Søborg, Capital Region of Denmark, DK

Research & Development, Regulatory Affairs
Denmark - Søborg

Join Regulatory Affairs and become part of a fast-changing environment where engaged people do their best every day to get Novo Nordisk’s medicines approved 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 place to work – but also quite challenging.

We are currently looking for a Senior Regulatory Professional with a strong scientific background and a genuine interest in being part of the future within Rare Endocrine Disorders projects.

About the department
RA Rare Endocrine Disorders Projects are reponsible for the regulatory deliverable for clinical projects and life cycle managements of approved products. We are 8 dedicated and highly engagaed 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 strategies 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.

The job
As a Senior Regulatory Professional, you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines. 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 briefing packages for meetings with Health Authorities, clinical trial applications, clinical trial protocols and reports and regulatory file for marketing authorisation.

Furthermore, you will be expected to contribute to the global regulatory strategies and tactics, be proactive and bold, challenge the discussions and contribute to project team decisions. You will among others interact with project management, medical and non-clinical specialists, statisticians and medical writers. You will also have the opportunity to contribute to projects for the improvement and maintenance of regulatory processes across the organisation.

Qualifications
We expect you to have a Master’s degree in Science and minimum five years of experience from working in Regulatory Affairs in the Pharma industry, preferably with clinical regulatory activities. 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. You also have strategic skills which you can combine with your ability to understand technical and operational challenges. You work according to high ethical standards and with the patient in mind, and you have a strong quality mind-set. You are a team player, but you also enjoy working independently. You have a positive attitude, good sense of humour, and you thrive in busy and changing circumstances, keeping your spirits high also under pressure.

Contact
For further information, please call Marianne Bork Samuelsen at +45 3079 6941.

Deadline
28th January 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.


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Ansøgningsfrist d. 28.01.2020
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Fuldtidsjob
Storkøbenhavn
Medicinal & Sundhed
Forskning & Udvikling
Medicinal & Sundhed
Projektledelse
Salg



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.

Placering
Novo Allé
2880 Bagsværd
Logo: Novo Nordisk A/S
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https://jobbank.dk/job/1450780/