Regulatory Writer (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Manufacturing

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Do you wish to assist Novo Nordisk ensuring a robust and stable supply of its products across the globe?

You can do this by being a part of our regulatory writing team, come join us!

The position
The regulatory documents behind submissions of new products, transfers of current products and changes made to our existing portfolio, are essential for us to meet our product supply demands at our own Novo Nordisk production sites globally, as well as contract manufacturing organisations around the world.

At Novo Nordisk, we are experiencing an unprecedented demand for our products, and we aim to support this bold supply challenge with effective and courageous efforts to provide speedy, accurate and concise regulatory documentation in order to meet to this challenge.

In this role, you will be responsible for:

• Writing, reviewing and editing manufacturing documents, which are owned by our department. This work is conducted in very close collaboration with Regulatory Affairs, who determine the strategy and our process and product subject matter experts.
• Attend kick-off meetings with our RA colleagues, internal project managers and other regulatory writers from different areas, who are also necessary for completing a submission. It is a complex process with many stakeholders, each required to deliver their part of the project.
• We work closely with the manufacturing process and product experts, who are responsible for the scientific content and manufacturing frame documents.
• Provide information and documents to health authorities and affiliates, via our RA counterparts based in Søborg and Bangalore, who reach out to us for amendments to the regulatory documents we author or questions from health authorities related to ongoing submissions. Often, these Q&A’S have short deadlines and are critical for submissions being completed in time. We respond to the Q&A’s, guided by our own experience and/ or the knowledge of our process and product subject matter experts in our department.
• Perform trade secrets screening of documentation when necessary and support life cycle management activities with our knowledge of the products and processes.
• Being able to juggle multiple tasks and know your stakeholder network is vital for navigating the multicultural and time-pressured aspect of the role. Expect great teamwork in order to achieve our team goals and in doing so, fulfil Novo Nordisk’s strategic goals for patient safety.

Qualifications
To succeed in this role, we expect you to have:

• An academic degree in Life sciences or a similar field.
• Experience from the pharmaceutical industry.
• Ability to work effectively in a cross-functional team environment.
• Have an interest in both the regulatory field and the scientific aspect of the products and processes.
• Excellent communication skills, with experience of working effectively with stakeholders.
• Knowledge of drug product manufacturing and experience with regulatory documentation is advantageous.
• Great written and spoken English and Danish language skills.
• An eye for detail is imperative.

On a personal note, you are meticulous, organized and have a structured and detail-oriented approach to everything you do. You take pride in delivering high quality documents and to do so you build and create a network to improve your knowledge and skills.

About the department
Our team sits within the Site Support and Improvement department, within IFP Manufacturing Development. Our purpose is to support the sites with our expertise process and product knowledge for marketed products and ensure that future manufacturing is possible by supporting product launches and transfers.
We are surrounded by Manufacturing development experts, who all also ensure that our products can get out to our patients as effectively as possible, regarding compliance, requirements from authorities and improvement and innovative opportunities.
We work across the departments, as one Manufacturing Development organisation.

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 call Senior Manager; Anneka Hastings at +4530798503

Deadline
16th July 2024
Please note that applications will be assessed on an ongoing basis and therefore the advert may close before the recruitment process is completed if we have proceeded with candidates to the screening or interview phase.
To apply, please submit your CV and a cover letter highlighting your experience and qualifications for this role. 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.