Senior Regulatory Writer (Denmark, Bagsværd)

Jobbeskrivelse
Placering
Bagsværd, Denmark

Jobkategori
Manufacturing

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Are you eager to shape the way we write regulatory submission documents for the approval of new finished products? Do you thrive in a team where we strive to ensure a smooth process and foster effective communication with health authorities during submissions and Q&A sessions?
If you are excited about setting the standards of regulatory submission documents for our growing pipeline of new injectable drug products, apply today and join us in the new Aseptic Manufacturing Science and Technology (AMSAT) team!

The position
As a Senior Regulatory Writer, you will be strongly involved in defining the cross-organizational collaboration to meet the needs in AMSAT going forward.
You can look forward to:

• Defining and keeping the overview of the regulatory storyline
• Creating documentation for our injectables product portfolio to ensure that the required product's quality is fulfilled and thereby securing patients’ safety
• Reviewing and implementing documentation for specifications, shelf-life stability studies, risk assessments, and regulatory submissions to health authorities
• Using your regulatory expertise to provide feedback, secure answers to questions from various health authorities, and keep in touch with them
• Structuring and coordinating complex documentation and submissions portfolio

You will do this in close cooperation with your colleagues across a number of departments in AMSAT, in the development departments CMC, QC, QA, production, and in regulatory affairs.
We offer an exciting and stimulating job that requires great energy, initiative, collaboration skills, and flexibility.

Qualifications
To be successful in this role, we imagine you:

• Hold an academic degree in Science within Pharmacy, Chemistry, Engineering or a similar field
• Possess hands-on experience either from the pharmaceutical industry, the regulatory area, OR that you can
• Bring expertise from the health authorities with either writing or reviewing regulatory documents
• Demonstrate strong planning and coordination skills in the writing work in line with an ambitious submission strategy
• Showcase proficiency in both spoken and written English

As a person, you thrive in busy environments and enjoy collaborating across departments, with many stakeholders involved. Challenges do not scare you and a quality mindset is at your core. You excel at time management, while being an engaged team player. Finally, you are fond of writing and good at creating an overview and prioritizing your tasks, even when deadline approaches.

About the department
In AMSAT we are responsible for the specifications of finished products and transfer of products from CMC to our production facilities in Product Supply and the support of our aseptic productions. Further, we seek innovative solutions to and optimizations of all our processes and write the associated documents to authorities worldwide plus answering Q&A’s.
The regulatory writers will have their base in a newly created team in New Products Introduction but will serve the needs across the whole AMSAT area throughout the products’ life cycle. This means that the team will have the responsibility for securing manufacturing document submission across Novo Nordisk’ injectables portfolio including established indications such as diabetes, obesity and haemophilia but also for new and emerging treatment areas from early phase through NDA/ BLA submissions and Life Cycle Management.

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, Maria Berggård Silow at +45-34485056

Deadline
5 January 2025.
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.