Ambitious and science driven regulatory CMC expert to work with innovative development ...

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Søborg

  • Regulatory
  • Søborg

Are you an ambitious and science driven regulatory CMC expert who wants to work with innovative development projects for the treatment of rare diseases? Are you able to take the lead and drive regulatory strategy for high impact projects and would you like to work together with decision makers and experts across multiple functions? Then you should join us and be part of an agile and global environment where we work to change the lives of patients living with rare blood disorders and rare endocrine disorders.

About the department

Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approval in all our markets. Regulatory Affairs is a fast-changing field, and the employees need a unique combination of scientific insight and the ability to navigate multiple agendas and stakeholders simultaneously to serve as Novo Nordisk’s advocates around the world to the benefit of our business and the patients we serve. This makes RA a fun and challenging place to work.

The RA CMC Biopharm area is part of Novo Nordisk project house in Søborg together with all other regulatory affairs functions. 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 products and development projects. The early project portfolio is rapidly evolving and therefore we are looking for new colleagues to join us.

The position
As a senior profile in our department, it is expected that you take lead on the regulatory strategies for high impact projects you will be working on. You will be responsible for ensuring timely and efficient submissions of regulatory dossiers and plans to Health Authorities. You will e.g. plan, coordinate and review the regulatory documentation in submission packages, responses to agency questions for global markets. This job will give you the opportunity to work independently and act as a resource for colleagues with less experience. It is expected that you are proactive, demonstrate leadership by setting RA direction in the projects, challenge the discussions and contribute to project team decisions for the product you work with.

The job offers ample opportunity for you to continue your individual development and stay updated within relevant regulatory and biotech disciplines. Your collaborative skills will be trained well and further developed, and you can expect to build an extensive internal network – just like we expect you to maintain your external networks to benchmark and bring up discussions with peers.

You will work in a fast-paced environment with tight deadlines and deal with the challenging reality of international communication across time zones, cultures and circumstances. The atmosphere is informal and good humour is always welcome.

Qualifications

You hold a M.Sc. and/or Ph.D. e.g. in Biochemistry, Pharmaceutical science or a similar university degree plus 5-7 years relevant experience from the pharmaceutical industry including some years of regulatory CMC experience either from the pharmaceutical industry or from a Health Authority. 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).

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 a strong communicator and can communicate scientific topics in a professional way in your contact with colleagues and health authorities. You 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 Nicolai Listov-Saabye +45 3075 4135 or Dorte Lunøe + 45 3079 0217.

Deadline
14. August 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.


Information og data

Denne ledige stilling har jobtypen "Laborant", og befinder sig i kategorien "Sundhed og forskning".

Arbejdsstedet er beliggende i Søborg.

Jobbet er oprettet på vores service den 19.5.2020, men kan have været deaktiveret og genaktiveret igen.

Rapportér
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Laborant
  • Søborg
Rapportér

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