Regulatory Content Specialist

2 weeks ago


Ballerup, Ballerup Kommune, Denmark Novo Nordisk Full time

We are currently seeking a highly skilled Regulatory Content Specialist to join our team in Malmö. In this role, you will play a crucial part in establishing regulatory documentation to support the development of new products within CMC Drug Product & Analytical Development.

About the Role

As a Senior Regulatory Writer, you will work closely with colleagues from other parts of CMC and manufacturing development, quality assurance, and regulatory affairs to create high-quality regulatory submission documents such as CTA (Clinical Trial Applications) and marketing applications related to the analytical field.

Responsibilities:
  • Develop and review regulatory submission documents, ensuring compliance with relevant regulations and guidelines.
  • Collaborate with cross-functional teams to gather information and ensure alignment across the organization.
  • Participate in the process of answering questions from health authorities worldwide related to our submissions.
  • Contribute to the development of our regulatory writing style based on continuous learnings and feedback.
Requirements

To be successful in this role, you will have a Master's degree in Pharmacy, Chemistry, Engineering, or a similar field, along with experience in the regulatory or analytical field. You should possess excellent communication skills, both written and verbal, and be able to convey complex technical information in an easily understandable manner.

You will also have experience in creating regulatory documentation, preferably in the pharmaceutical industry, regulatory area, or health authorities. Additionally, you should be proficient in English and have a flair for IT and process optimization.

About Us

Novo Nordisk is a global healthcare company with a strong focus on diabetes and chronic kidney disease. We are committed to creating a workplace that values diversity, equality, and inclusion, where everyone has the opportunity to thrive and grow.

What We Offer

We offer a competitive salary of around 125,000 DKK per year, depending on your qualifications and experience. You will also receive a comprehensive benefits package, including access to training and development opportunities, flexible working hours, and a dynamic work environment.

Join us in shaping the future of healthcare and become a part of a talented team that is dedicated to making a difference in people's lives.



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