About the role
Regulatory affairs officers often work within the pharmaceutical, biotechnology, or medical device industries and ensure that companies' products comply with laws and regulations. They usually have an academic background in pharmacy, law, or a similar discipline. Their knowledge of legislation and guidelines is crucial for navigating the regulatory environment.Responsibilities
Regulatory affairs officers are responsible for preparing and submitting documentation to authorities for the approval of new products or changes to existing ones. They monitor and report on regulatory requirements and updates. Their work also involves collaborating with other departments to ensure that all aspects of a product are in line with current regulations.Skills and tools
Regulatory affairs officers must have a thorough understanding of legislation and guidelines related to their sector, as well as the ability to interpret and implement these. They often use databases and software for document management. Strong communication skills and attention to detail are essential for successfully managing the complex processes. Common competencies demanded by employers are monitor affärssystem, läkemedel/sjukvårdsprodukter and bygglov.