- Life-cycle management of the quality documentation of products to enter the company's established portfolio.
- Work with approved drug products and chemical drug substances.
- Perform regulatory assessment of the documentation to support data integration, participate in planning variation applications for different types of changes and prepare regulatory strategies for the variation applications.
- Perform regulatory assessment of change control cases and support renewal applications.
- Work in RA product teams where you in close cooperation with other Regulatory Affairs colleagues will plan and project-manage CMC related aspects regarding submissions of variations for the integration of products.
- Part of a cross-functional team, which have the responsibility to integrate and maintain the quality documentation and handle CMC-related issues for the drug products and drug substances.
- General activities in the department, including improving and implementing integrated regulatory business processes and share new Regulatory Intelligence knowledge.
- 2-5 years’ experience from Regulatory Affairs within CMC life-cycle management of approved products;
- Knowledge of regulatory requirements within EU and a broad knowledge of regulatory requirements in other markets and countries outside EU;
- Clear focus on agreed objectives, even when working with tight deadlines.