Role DescriptionThe Admin Regulatory Affairs is responsible for the registration document(s) procurement, preparation and coordination. The Admin Regulatory Affairs will serve as liaison with other functional teams at the site in support of registration activities and generation and management of required documentation. You will work in collaboration with the Site RA CMC and other Global/Regional Teams as needed.
Responsibilities- Coordinates legalization and delivery of registration documents following the instructions provided in the request. - Maintains tracking and organization of documentation, including uploading in CSD tool or other document repository. - Supports the Site Regulatory CMC in the compilation and preparation of marketing application and post-approval submissions as needed. - Maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses.
Requirements- Knowledge of Good Manufacturing Practices (GMP) and good documentation practices is a pre - Strong written and oral communication skills - Proficient use of MS Office tools, SharePoint and strong computer aptitude. - Must have ability to work within team environment, but maintain a level of autonomy for managing daily tasks and activities - Solid working knowledge on document management systems such as Documentum.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Britt Gabriels.