Regulatory Professional for RA CMC Biopharm

Arbejdssted
Søborg, Denmark
Oprettet
7. februar 2019
Udløber
22. marts 2019
Ref
224027
Join a fast changing environment where engaged people do their best every day to obtain and maintain clinical trial applications and market 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?

About the department

The department RA CMC&Device Biopharm 2 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 14 highly skilled and dedicated people involved in every CMC aspect concerning marketed products and projects in development within Haemophilia. The project portfolio is developing and in order to be able 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

Depending on your experience you will either work with a product where the first marketing authorisations (MAA) will be obtained in 2019 and the focus is on the transition from development to Life Cycle Management (LCM) and roll out of the product to relevant countries worldwide or you will work with an established product with LCM and continued roll out to relevant countries.

Regardless of the position you will be expected to provide regulatory CMC input, be proactive, challenge the discussions and contribute to project team decisions for the product you work with.

You will prepare the regulatory strategies and handle the submissions worldwide i.e. hands on experience with handling of LCM CMC variations are a preference.

In addition, you will plan, coordinate and review regulatory documentation, chair internal working groups and be our primary regulatory point of contact for the Development, Production and Product Support units in Novo Nordisk.

Qualifications

We expect you to have a Master of Science in Pharmacy or a similar university degree plus experience within regulatory aspects of CMC.

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 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 eager to learn, organised, detail oriented and a proactive problem solver. You enjoy working in a team and in a project oriented organisation. 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.

Contact

For further information, please contact Tina Meinertz Andersen at +45 3079 8717.

Deadline

5. March 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.

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