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Senior Regulatory Professional CMC

Novo Nordisk A/S

Gladsaxe, Storkøbenhavn

Indrykket
21-10-2020
Kontakt
Novo Nordisk A/S
Vandtårnsvej 108
2860
Søborg
Tlf
30757225
Praktisk information
Oprettet
21-10-2020
Udløber
23-10-2020
Kviknummer
330394878
Jobtype
Fuldtid
Arbejdsområde
Jura
Stillingsbetegnelse
Advokat
Erfaringer - I højere grad
Ikke angivet (Jura og retsvæsen)
Sprog
Dansk Læse/ tale

Join an agile and global environment where we obtain and maintain clinical trial applications and market authorisations worldwide for all Novo Nordisk medicinal products. The employees in Regulatory Affairs (RA) have a unique combination of scientific insight and the ability to navigate multiple agendas and stakeholders simultaneously. This makes RA a challenging place to work. Are you up for this challenge?

 

About the department 

RA CMC & Device is part of Novo Nordisk R&D organisation and is sited in Novo Nordisk project house in Søborg in close contact with other RA functions. In the Biopharm area we are a group of 24 highly skilled and dedicated people divided into two departments and involved in every CMC aspect concerning our Biopharm and Haemophilia marketed products and development projects. The early project portfolio is evolving and therefore we are looking for a new senior colleague to join.

 

Our dedicated group prepares global regulatory strategies for the CMC part of clinical trial applications, marketing authorisation applications and post approval CMC variations. The stakeholders range from CMC Development and Product Supply to Clinical RA as well as affiliates and global health authorities.

 

The position 

The Senior Regulatory professional is responsible for providing strategic input to projects, for developing global Regulatory CMC strategies, provide support and for execution of regulatory submissions for development projects and products throughout life cycle management. You will be responsible for planning, coordinating and reviewing regulatory documentation e.g. supporting preparation of applicable sections of submission packages, responses to agency questions for global markets and Agency Meeting Packages. It is expected that you are proactive, able to take leadership, challenge the discussions and contribute to project team decisions for the product you work with.

 

Qualifications 

Preferably, you hold a M.Sc. and/or Ph.D. e.g. in Biochemistry, Pharmaceutical science or a similar university degree plus several years relevant experience from the pharmaceutical industry including some years of regulatory CMC experience either from the pharmaceutical industry or from a medical agency. You have strong scientific and technical skills, as well as a thorough understanding of related pharmaceutical operations (e.g. manufacturing, process development, analytical, and quality assurance).

 

You communicate topics related to protein chemistry/analytical chemistry/manufacturing of drug substances and drug products scientifically and professionally in your contact with colleagues and health authorities.

 

On a personal level you are curious to learn, well organised and a proactive problem solver. You enjoy working in a team and in a project-oriented organisation. You are good at communicating and are completely comfortable speaking and writing in English.

 

In addition, you thrive in an environment with changing circumstances and bring a can-do attitude and a healthy sense of humour. You keep focus on jointly moving the projects, can work independently and bring an innovative mindset seeking novel solutions to the challenges we face.

 

At Novo Nordisk, your skills, commitment and ambition help us change lives for the better. In exchange, we offer you a chance to work with extraordinary talent and to develop professionally and personally.

 

Contact
For further information please contact Dorte Lunøe + 45 3079 0217.

 

Deadline
Please apply for the position no later than 23. October 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.

Ansøg nu
Virksomhedsinformation
Novo Nordisk A/S
Vandtårnsvej 108
2860
Søborg
Tlf
30757225
Praktisk information
Oprettet
21-10-2020
Udløber
23-10-2020
Kviknummer
330394878
Jobtype
Fuldtid
Arbejdsområde
Jura
Stillingsbetegnelse
Advokat
Erfaringer - I højere grad
Ikke angivet (Jura og retsvæsen)
Sprog
Dansk Læse/ tale
Beliggenhed