Regulatory Affairs Specialist
Edison-New Brunswick Metro Area, NJ
Preparing, compiling, reviewing and processing the regulatory submissions documents including both pre-approval and submissions such as IND, NDA/BLA, MAA, amendments/supplements, annual reports, etc.
Coordinating and consulting with other concerned functions on the content, and assembly of regulatory documentation and ensuring consistency, completeness and adherence to standards for all the regulatory submissions.
Assist with regulatory communications with the FDA for assigned products and activities, including preparing and formatting of FDA meeting requests, briefing book, meeting rehearsals/slides, meeting minutes of the FDA meetings and the generation of responses to the FDA queries.
Support the compilation, development, submission, and maintenance of worldwide 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
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
Familiarity with pharmaceutical regulatory affairs.
BS/BA in a scientific field.