Senior Regulatory Affairs Professional in CMC

Novo Nordisk A/S





Søborg, Capital Region of Denmark, DK

Join a fast changing environment where engaged people do their best every day to obtain and maintain clinical trial applications and marketing authorisations worldwide for all Novo Nordisk medicinal products across the globe. The employees in Regulatory Affairs (RA) have a unique combination of scientific insight and the ability to navigate many agendas and stakeholders simultaneously. This makes RA a truly interesting place to work but also quite challenging. Are you up for this challenge in the near future and would you like to join fast paced Global RA organisation?

About the department
The department RA CMC Biopharm 1 is part of RA CMC&Device in Regulatory Affairs and is situated in the Novo Nordisk project house in Søborg together with other regulatory affairs functions.

We are a group of 7 highly skilled and dedicated people involved in the many CMC aspect concerning marketed products and projects in development within Growth Disorders. The department is very versatile and in addition to new MAAs/NDAs and LCM of current MAAs/NDAs we also support the Novo Nordisk organisation with the Regulatory Framework for Site Master Files and undisputed regulatory advice for Local Manufacturing projects & Primary Packaging. To handle the tasks and challenges within our area of responsibility we are looking for a new colleague to the department.

You will work with experienced and engaged colleagues and work closely with many different stakeholders within Novo Nordisk headquarters and affiliates. In this dynamic environment, our dedicated group prepares worldwide regulatory strategies for the CMC part of clinical trial applications, marketing authorisation applications and post approval CMC variations. Furthermore, the department is responsible for interactions with regulatory authorities worldwide.

The position
We are looking for a Senior Regulatory Professional that will work with a development project approaching the submission of a new marketing authorisation application and further roll out of the product to the rest of the world. The team have just successfully made its first submission. You will join a team ready for the first round of Q&A and you will play a key role in ensuring a successful response to the Drug Substance part of the dossier.

You will compile, submit and maintain applications for the product you work with. You will be expected to provide regulatory CMC input, be proactive, challenge the discussions and contribute to project team decisions, ensuring high quality CMC input to the regulatory strategies and submissions including Q&As. You will be part of a team of four and be one of our primary regulatory points of contact for the Development project.

We expect you to have a Master of Science in Pharmacy or a similar university degree plus a couple of years of experience with regulatory aspects of CMC. We expect the candidate to have a proven track record in authoring/review both Drug Product and Drug Substance CTD sections of a Dossier for Biotechnological/Biological Products.

You have a strong interest and good understanding of regulatory guidelines and regulatory affairs and can apply this in your day to day work. Furthermore, you have some years of regulatory experience either from the pharmaceutical industry or from a medical agency.

In addition, it would be valuable if you have good general knowledge and interest in manufacturing processes for proteins and/or injectable drug products. You are able to communicate scientifically difficult topics related to protein chemistry/analytical chemistry/manufacturing of drug products so it is easy to understand for health authorities and you find this process very interesting.

On a personal level you demonstrate that you are organised, detail oriented and a proactive problem solver. You enjoy working in a team and in a project oriented organisation and you have a natural drive. You are able to make decisions without formal authority. You communicate well and are completely comfortable speaking and writing in English and preferably also in Danish.

In addition, you thrive in busy and changing circumstances and bring a can-do attitude and a healthy sense of humour. You keep focus on jointly moving the projects and are able to work independently, be challenged and find new solutions.

Working at Novo Nordisk
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.

For further information, please contact Rehana Mukhtar at +45 3077 6145

or Nicolai Listov-Saabye at +4530754135.


22. September 2019

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.

Ansøgningsfrist d. 22.09.2019

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Kemi, Biotek & Materialer
Medicinal & Sundhed
Forskning & Udvikling
Medicinal & Sundhed

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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