Regulatory Affairs Specialist
Cambridge Metro Area, MA
This individual will support the US Regulatory Leads based in Bridgewater, NJ and Cambridge, MA. Coordinating and consulting with regulatory leads on the assembly of regulatory documentation and ensuring consistency, completeness and adherence to standards for all the regulatory submissions. Assist with preparing and formatting of regulatory documenation and meeting slides. Support the compilation, development, submission, and maintenance of US regulatory filings. Track regulatory project status and informational documents. Creating timelines and tracking deliverables to timelines to ensure that all submissions are submitted on-time. Assist regulatory leads with the creation of electronic table of contents and request for publishing requests in the regulatory electronic document management system.
Good oral and written communication skills
Experience with Veeva electronic document management system
Project management skills, including but not limited to creation of timelines, organization of meetings, meeting minutes, demonstrated record of coordinating across stakeholders in a matrixed organization.
Formatting of Microsoft Word templates.
BA/BS in a scientific field