RA Cell Therapy Expert

Category:  Regulatory
Location: 

Søborg, Capital Region of Denmark, DK

   

Do you dream of a career with a global pharmaceutical company built on life-changing innovations? Does working with highly talented and engaged colleagues from many different professional backgrounds and cultures inspire you? Would you like to go to work knowing that what you do helps bring our innovative treatments and devices to people who need them, faster? If so, then you could be our new colleague in Regulatory Affairs. Apply today!

 

The position


As our new colleague, you will demonstrate leadership by setting strategic regulatory direction for high impact projects in the ATMP space such as cell therapy projects and other innovative investigational medicines. Your key responsibility is to ensure that regulatory pathways do not hinder scientific progress. Working closely together with decision-makers across multiple functions in a global environment, you thrive with the challenging reality of international communication across time zones, cultures, and circumstances.

 

In addition, you will also be responsible for:

  • Guiding and mentoring junior colleagues
  • Participating in cross-functional expert fora’s and
  • Contributing to improvement projects

 

Our commitment to innovation also applies to the way we work: We embrace remote work and the hybrid workplace. Whether you prefer to work from home, at the office or to blend the two to your liking.

 

This position can either be connected to our headquarters in Søborg, Denmark – or for candidates currently based in the UK, in our offices in Gatwick, UK.

 

Qualifications

You hold a Master´s degree and/or Ph.D. in Biochemistry, Pharmaceutical Sciences, or a similar degree in a relevant scientific field. You have acquired advanced experience working with innovative medicines like Cell and Gene Therapy, RNA based technologies and have acquired solid Regulatory CMC experience either from the pharmaceutical industry or from a health authority.

 

We imagine that you have minimum 8 years of experience with above and have hands-on experience within several of the areas below:

  • Health Authority interactions,
  • Breakthrough therapy projects,
  • RA strategies for Development Projects and Established products
  • Submission of CTA/IND and BLA/MAA 
  • Post-approval change management

 

In addition, you have a strong scientific and technical mindset and a thorough understanding of the pharmaceutical value chain and related pharmaceutical operations (e.g., manufacturing, process development, analytics, and quality assurance). You also have strong communication skills in both written and spoken English, and the ability to communicate topics related to protein chemistry/analytical chemistry/manufacturing of drug substances and drug products scientifically and professionally. Finally, you are unfazed by a fast-paced work environment with tight deadlines.

 

About the department

 

Regulatory Affairs professionals play an important role in ensuring that all new Novo Nordisk treatments and devices are developed with compliance in mind, to get them to people in need as fast as possible. Liaising between relevant authorities and Novo Nordisk specialist teams, regulatory affairs professionals are involved through all phases of product development and roll-out.

 

Regulatory affairs professionals come from many different academic and professional backgrounds, bringing valuable insights and expertise to the team and the company to ensure minimum time to market. This makes Regulatory Affairs a truly multi-disciplinary area with high professional standards and excellent opportunities for fast-paced professional development and career progression.

 

Working at Novo Nordisk

 

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. 

 

Contact


For further information please contact Director Nicolai Listov-Saabye: +45 3075 4135.

 

Deadline


28 August 2022.

 

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.

 

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.