Advanced Regulatory Writer

Job title:

Advanced Regulatory Writer

Company:

Novo Nordisk

Job description

Are you passionate about understanding the needs of medicines authorities and re-writing our internal documentation into regulatory submissions?If you have experience in the regulatory field and/or within analytical chemistry, you might be the perfect fit for our Regulatory Writer position.The positionAs a Regulatory Writer, you will take charge of defining the regulatory storyline and creating documentation for all our injectable products within the analytical part of our regulatory documents.This includes:

• Writing and reviewing documents for regulatory submissions such as analytical procedures and analytical method validation reports.
• Participate in answering questions from health authorities worldwide in close collaboration with colleagues across various departments – e.g. Analytical Science & Methods, Quality Control, Quality Assurance, Manufacturing facilities and Regulatory Affairs.

This role offers an exciting and stimulating opportunity that requires curiosity, responsibility, initiative, collaboration skills, and flexibility. You will be part of a team of 6 dedicated Regulatory Writers.Qualifications
To be successful in this role, we are looking for someone who ideally has:

• A master’s degree within Pharmacy, Chemistry, Engineering, or a similar field.
• Experience either from Health Authorities e.g., Danish Medicines Agency, the pharmaceutical industry or the regulatory area with writing or reviewing regulatory documents.
• Good knowledge about Analytical Chemistry.
• A passion for writing and strong writing skills in English.
• Good organizational and task prioritization skills.

As a person you are curious, and challenges do not scare you. You have a structured and detail-oriented approach to everything you do, and you never compromise on quality. You enjoy being part of a team and you excel at time management.About the department
AMSAT ASAT Analytical Projects & New Technologies is a department with approximately 45 employees. We focus on bringing new and improved products to patients. We own the analytical sections of regulatory dossiers for aseptic manufactured drug products, and we scout for and develop new analytical technologies and solutions.
Our work involves managing projects, overseeing regulatory documents, and ensuring our laboratory equipment runs smoothly.
Together, we drive change by always seeking improvements within our processes and developing new ways of working.Working at Novo Nordisk
At Novo Nordisk we use our skills, dedication, and ambition to help people with diabetes and other chronical diseases and change their lives. By working with us you will have the opportunity to do the same in a global business environment.Contact
If you have any questions about the job, please don’t hesitate to contact Manager, Karen Kirketerp on +45 30758399.Deadline
9 March 2025You do not need to attach a cover letter to your application, but please include a few sentences in your resume or CV about why you are applying for the job. To ensure an efficient and fair recruitment process, please refrain from adding a photo to 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.

Expected salary

Location

Gentofte, Hovedstaden

Job date

Sat, 15 Feb 2025 23:29:37 GMT

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