CMC Regulatory Affairs seeking specialist with strong collaboration skills

• Regulatory
• Søborg

Do you possess a good business understanding, and would you be energised by making a difference in a truly global organization? Are you able to take the lead on regulatory strategy on high impact projects and would you like to work together with decision makers and experts across functional and cultural distances? And are you seeking new opportunities where you can employ your knowledge of both regulatory guidelines and the world of CMC and balance it all with global manufacturing? Then take the time to read on and expedite your application to us, so that our future together may begin now.

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 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 benefit for our business.

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

Our primary stakeholder responsibility is with Product & Process Development, the global manufacturing sites and the Novo Nordisk Supply Chain planning teams. We are engaged in projects with high impact for the organisation as a whole, supporting the demand of increasing capacity and flexibility in our global manufacturing network, while always keeping us ready for an exciting future by exploiting the opportunities the latest technology provides.

We have a close collaboration with our Regulatory Affairs 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. In your new team, you will have colleagues to back your decisions, provide you with support and expertise, and who will expect you to be there for them as well.

The job

The job will not be easy, but it will be fun. It will surely challenge and develop your business understanding and your ability to work in a global cross functional organization, when you gather insights from your many dedicated colleagues and transform them into value in your reporting to management.

As a senior profile in our department, you take lead on the regulatory strategy on high impact projects. You will develop best practices and knowledge of internal or external business issues to improve products or services. Your academic skills will be put to good use – not only will you be responsible for the regulatory support to Local Manufacturer projects and for ensuring the timely and efficient submission of regulatory plans to Health Authorities. You will also be handling scientific and trade secret reviews and be the primary liaison officer between Global manufacturing, the CMR RA affiliate and our Project Managers.

This job will give you the opportunity to work independently and act as a resource for colleagues with less experience and you will quickly be perceived as the go-to expert within one or several key processes across the business area. At the same time, it will require that you challenge process understanding, value creation and business output in our discussions and contribute to project team decisions for any 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. Some travel activities, primarily to Bangalore, should be expected.

Qualifications

You hold a M.Sc. and preferably also a Ph.D. e.g. in Biochemistry, Pharmaceutical science or similar. You have at least 5 years of 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, analysis and quality assurance).

Like us, you are goal-oriented, you organise your time and tasks well, and you are proud to take responsibility for your work. You are ambitious and have a great interest in developing your skills, taking your expertise to the next level in a complex product and business setup.

You thrive on solving complex tasks by constructive communication based on your knowledge and understanding of Regulatory Affairs and you never compromise on quality. You use your dedicated and determined approach to complete your tasks in close collaboration with your colleagues, and you look forward to share knowledge and experiences with them. You work independently, you follow through on your ambitious initiatives and you contribute positively and actively to the friendly team environment we enjoy. Fluency in written and spoken English is a must.

Contact

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

Deadline

9. 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.