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Do you want to be part of an ever-changing environment, with numerous ongoing and future projects related to capacity, manufacturing projects and new product launches? Then you should continue reading and consider becoming part of our team.

We are expanding the Regulatory Affairs (RA) facility team that is responsible for the regulatory documentation of facility, equipment and cleaning for the diabetes, obesity portfolio and manufacturing sites.

Apply now for this exciting opportunity!

The position

Key responsibilities in this role will be:

  • To drive, coordinate and ensure scientific progress is turned into regulatory solutions. Coordinate readiness and quality of required documentation and details for processes relating to facilities, equipment, and cleaning
  • Hands-on ownership of the documentation
  • Demonstrate leadership by setting strategic regulatory direction for high-impact projects in the area. This can be accomplished through facilitating the regulatory approval process, health authority interactions in collaboration with the affiliates and handling day-to-day tasks within our regulatory systems and global processes

The job involves a high degree of planning, coordinating, execution of tasks and projects. You will be expected to continuously update or adapt to changes in work processes. The role requires the ability to work effectively with people from different functions and organisational levels, calling for high cultural awareness and the necessary skills to encourage and influence colleagues, governance, and key stakeholders.

This is an opportunity for you to continue your individual development and stay updated within relevant regulatory and biotech disciplines and you can expect to build an extensive internal network. Our commitment to innovation also applies to the way we work - whether you prefer to work from home, at the office, or to blend the two, we will find a way through.

Qualifications

To be successful in this role, you need to have:

  • University degree in natural science or similar
  • 5-8 years of documented professional experience from the pharma industry; previous regulatory experience is an advantage, but not a demand
  • Experience from a similar position or extensive GMP knowledge within manufacturing would be an advantage
  • Advanced level of written and spoken English
  • Hands-on experience within several of the areas below:

- navigating within an environment of tight timelines, high complexity, non-standards, and diverse tasks in known and new therapy areas

- excellent analytical skills, systematic approach to identify root causes and propose innovative ways to solve problems

- ability to communicate complex scientific procedures with technical proficiency both orally and in writing

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.

You will join a relatively new team – a department responsible for project management and scientific input and regulatory strategies and documentation for capacity and manufacturing projects, as well as being responsible for enabling fast approvals for world-wide roll-out and approvals. The department is currently being established and developed; hence you will have the opportunity to be part of an impact this journey.

Our primary stakeholder in the department is the global manufacturing sites together, as well as central Supply Chain management areas. We are engaged in high potential projects to support the demand of increasing capacity and flexibility in our global manufacturing network and implement newest technology. We also have a close collaboration with our RA CMC (Chemistry, Manufacturing and Controls) colleagues in Bangalore India, where part of the RA facility role lies.

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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.

Contact

For more information, please contact Malene Østergaard Jørgensen at +45 3079 5844.

We are looking for several Regulatory Affairs 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.

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Information og data

Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Søborg.

Jobbet er oprettet på vores service den 28.10.2022, men kan have været deaktiveret og genaktiveret igen.

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

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