Senior Regulatory Writer

Job title:

Senior Regulatory Writer

Company:

Novo Nordisk

Job description

Are you passionate about the regulatory submission process and writing? Do you have experience from working within the analytical or regulatory field? Can you gather im-portant cross-functional knowledge and ensure regulatory alignment across the team?Then you are the new Regulatory Writer, we are looking for!Apply today and join us for a life-changing career!The position
As a Senior Regulatory Writer you will work closely with colleagues to establish regulatory documentation to support development of new products. In CMC Drug Product & Ana-lytical Development, we support the entire drug development portfolio, and you will therefore get a chance to dig into a lot of exciting drug development projects.You will take part in shaping the way we write our regulatory documents based on con-tinuous learnings and feedback and be a part of a regulatory writer network covering API, drug product, and analytical procedures, striving to develop and improve the regu-latory writing in Novo Nordisk. These initiatives can include everything from process def-inition and optimisation to the use of AI technology.Your key activities include:

• Write and review regulatory submission documents such as CTA (Clinical Trial Ap-plications) and marketing applications related to the analytical field.
• Take part in the process of answering questions from health authorities across the globe related to our submissions.
• Collaborate with colleagues from other parts of CMC and manufacturing develop-ment, quality assurance and regulatory affairs.
• Take part in giving content to the way we write our regulatory documents based on continuous learnings and feedback.

Qualifications
We are currently looking for a colleague with experience within the regulatory or analyti-cal field as well as a Master’s degree within Pharmacy, Chemistry, Engineering, or a similar field.Furthermore, you:

• Can turn detailed technical information into easily, understandable regulatory documentation.
• Are a strong communicator who can convey regulatory information.
• Are fond of writing and you are good at creating an overview and prioritizing your tasks; even when deadline approaches.
• Can write with full professional proficiency in English.
• Have experience either from the pharmaceutical industry, the regulatory ar-ea or from the health authorities with either writing or reviewing regulatory documents.
• Enjoy improving the way of working with regulatory documentation; it would be considered an advantage if you have flair for IT and process optimisation.

On a personal level you 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. As a colleague you are open-minded, enjoy sparring and great colleagueship.

About the department
Your new department, CMC Drug Product and Analytical Development – Project Office, consists of 50 employees located in Måløv. The department is involved in early and late-stage drug product development, analytical development and chemical and biological characterization of new entities moving through the clinical phases of drug product de-velopment.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 ex-perimentation, 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 pa-tient care.Contact
For further information, please contact Associate Manager Rikke Bloch at +45 30795741.Deadline
3 January 2025Applications will be reviewed continuously, and interviews will be conducted during the posing period, so please do not hesitate to apply.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.

Expected salary

Location

Hovedstaden

Job date

Thu, 28 Nov 2024 23:26:59 GMT

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