Regulatory Affairs Specialist, Product Lead

  • Regulatory
  • Søborg

 

   

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 dedicated employees in our unit need both keen negotiating skills and scientific insight to serve as Novo Nordisk’s advocates around the world to the befit for our business.

 

About the department

The RA CMC Established products is situated in the Novo Nordisk project house in Søborg together with other regulatory affairs functions. We are a group of 15 highly skilled product leads, project managers and RA CMC specialists responsible for the handling regulatory strategies of business critical and complex projects for established products within our Diabetes and Biopharm portfolio.

 

Our primary stakeholders responsible are Product & Process Development and the global manufacturing sites together with Novo Nordisk Supply Chain planning. We are engaged in high impact projects to support the demand of increasing capacity and flexibility in our global manufacturing network and implement newest technology.

 

We have a close collaboration with our RA CMC colleagues in Bangalore India who is responsible for the daily task of LCM support to stakeholders within Novo Nordisk global manufacturing sites, our affiliated offices and health authorities around the world.

 

The job

The job will not be easy, but it will be fun, and it will challenge and develop your business understanding and your ability to work in a global cross functional organization.

 

As a Regulatory affairs specialist, Product Lead, you take lead on the regulatory strategy on high impact projects. The job involves high degree of planning, coordinating and submitting variation applications. 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.

 

The job requires that you continue your individual development and that you keep being updated within relevant regulatory and biotech disciplines and uses your external network to benchmark and bring up discussions with peers.

 

You will work in a fast-paced environment with tight deadlines, cross-departmental collaboration and deal with the challenge of international communication. The atmosphere is informal and good humour is always welcome. Some travel activities, -primary to Bangalore, are expected

 

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 are organised, able to think out of the box, dare to take risks and exhibit a strong driver. You demonstrate winning attitude, keep your spirits high and stay calm even when under pressure. You are a strong team player whom is also able to work independently. Fluency in written and spoken English is a must.

 

Contact

For further information, please call Manager Jacob Larsen +45 3079 1441.

 

Deadline

21. July 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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