Regulatory Affairs Specialist III

Job Title -Regulatory Affairs Specialist III
Location -Bridgewater NJ
Duration - 9 Months

• Manager will consider candidates to be based in either Bridgewater New Jersey or Cambridge Massachusetts. Please specify on resume which location candidate is being submitted for.
• 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.

Required Experience:

IC