Regulatory Affairs Associate
... cross-functional teams, ensuring that regulatory submissions comply with local and international ... attention to detail. Proficiency in regulatory submission tools and databases. Ability to ...
... cross-functional teams, ensuring that regulatory submissions comply with local and international ... attention to detail. Proficiency in regulatory submission tools and databases. Ability to ...
... databases. Develop the regulatory application strategy, including the submission requirements, associated costs and time ... and experience).Demonstrates comprehensive regulatory expertise including preparation and submission of CTAs, the applications for ...
... activities, ensuring timely and successful regulatory submissions. Interact with regulatory authorities and participate in meetings and negotiations to address regulatory issues and ensure alignment with ...
... cooperation with RA Biopharma. Coordinate submission of these dossiers to the appropriate regulatory authorities (e. g. Paul-Ehrlich- ...
... a subject matter expert in regulatory processes, laws, and regulations, with a comprehensive understanding of how regulatory policy is shaped and developed ... , assessment, and communication of global regulatory changes to all stakeholders. Ready ...
... of regulatory submissions. In this role, you act ... entry and regulatory master data management : Managing data to ensure accurate regulatory reporting. Ensuring sufficient planning and execution of electronic submissions : Coordinating internal and external ...
... for planning, coordinating, and overseeing regulatory submissions required for maintaining marketing authorizations ...
... eCTD Manager, Trackwise, or other regulatory information management systems Submission and publishing tools. Knowledge of regulatory IT systems landscape and implementation ...
... include the following activities: Shaping regulatory strategies and submission plans related to new registrations ... and implementation of the necessary regulatory activities for the preparation and submission of applications for new registrations ...
... include the following activities: Shaping regulatory strategies and submission plans related to new registrations ... and implementation of the necessary regulatory activities for the preparation and submission of applications for new registrations ...