Senior Regulatory Writer

Category: Manufacturing

Location:Måløv, Capital Region of Denmark, DK

• 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.

• 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.