Senior Regulatory Affairs Associate (Regulatory Affairs Generalist)

**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 updates, CMC changes)• Ability to manage/coordinate impact assessments for technical change...