Regulatory Affairs CMC Expert, Transformation project

Category:  Regulatory
Location: 

Søborg, Capital Region of Denmark, DK

   

Would you like to play a role in one of the biggest transformation projects underway in the Novo Nordisk Development organization? Are you motivated by the opportunity to make a meaningful impact on the lives of millions of people in need of Novo Nordisk’s new life-changing treatments?

We are now searching for a Regulatory Affairs (RA) Chemical, Manufacturing and Controls (CMC) Expert to be part of a team that will expand and accelerate the Fit4Take-off Label and submission engine to support our transformation journey.

If it sounds interesting for you, then this is your chance to join us. Apply now!


The position

Nearly 2 years ago, we launched Fit4Take-off (F4TO)- a ‘Moonshot’ aspiration to be ready for submission of new drugs to medical authorities just 4 days after Last Patient Last Visit in clinical trials: in our 4 most important markets AND secure launch only 4 days after approval.

The Fit4Take-off programme is now a highly visible and recognised transformation programme, with a clear purpose to bring innovative treatments faster to our patients. The “Label Submission engine” drives changes in mindset, processes and digitalisation. As a representative of Regulatory Affairs CMC, you will be perceived as a valued business partner across the organisation, and you will join a fun, supportive, and inclusive work environment.

In this position your responsibilities will be:

  • Leading optimisations and continuous improvements of our RA CMC processes
  • Creating initiatives to optimise and accelerate the submission procedures such as driving the digitalised submission of data to the Health Authorities
  • Part of a F4TO matrix team lead by a project manager. This team will have responsibility for deliverables within the Label & Submission engine. The team will secure learnings and increase collaboration across RA areas and be able to move at a fast pace
  • Interacting with engine leads, business owners and leaders of the drug projects, you will be involved in bringing forward new ideas, testing ideas and the importantly subsequent anchoring these transformations in the organisation

The position will be anchored in Line of Business and report to Associate Director of RA CMC Biotech and Rare Disease.

 

Qualifications

As an ideal candidate, you have:

  • Strong background in Regulatory Affairs CMC and broad understanding of drug development
  • Relevant Master’s degree in life sciences
  • Very solid process experience and Subject Matter Expert (SME) knowledge for Regulatory CMC processes
  • Digital mindset and strong IT skills
  • Good communication skills and fluency in written and spoken English
  • Ability to manage and prioritize tasks and projects

On a personal level, you have a high level of drive and result-orientation while being a team player. You are curious and innovative by nature and like to be challenged. You thrive in agile and matrix set-up’s and are comfortable interacting with stakeholders at different organisational levels. Finally, you have excellent analytical skills, systematic approach to identify root causes and propose innovative ways to solve problems.

 

About the department

Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring fast regulatory submissions and approvals in all our global markets. In RA CMC Biotech & Rare Disease we are a group of more than 40 highly skilled and dedicated regulatory professionals divided into three departments and involved in every Regulatory CMC aspect concerning our Rare and Other Serious Chronic Disease products. The project portfolio is rapidly growing; therefore, we are looking for an experienced profile to join us and optimise the way we work in projects within ATMP and SiRNA portfolio, small molecules, and protein-based biologics.

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.

 

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 about the position, please contact Ana Mora Agudo at +45 30750292.

 

Deadline

15 February 2023. Applications will be reviewed continuously when received and candidates may be called for interview before the deadline.

We are looking for several similar profiles at Novo Nordisk now. Therefore, Hiring Managers from different teams might also look at your application.

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.