Senior Regulatory Affairs Associate (RA Generalist)
When our values align, there's no limit to what we can achieve.
Key Accountabilities:
Project Execution
Previous experience working in industry in support of Global and/or local Regulatory teams, with comprehensive understanding of regional and global regulatory requirements, guidelines and processes and in-depth expertise on local health authority management
• Strong knowledge of post-authorization lifecycle maintenance procedures e.g. variations, renewals, PSURs, etc, timelines and requirements, to support maintenance of multiple licenses, including management of HA interactions and responses to questions
• Use of document management tools (internal systems) and external platforms
• Prepare, organize and coordinate local specific documentation e.g. module 1 to meet national submission requirements and be responsible for keeping up-to-date local national systems as per local legislation ( renewals, PSURs, label upda...