Regulatory Affairs Specialist III (Clinical)
Cambridge, Massachusetts, US Cambridge, MA 2142
Job Title: Regulatory Affairs Specialist III (Clinical)
Location: Cambridge, Massachusetts, US
Job Type: Contract
Duration: 6 Months With Possible Extension
Roles & Responsibilities:
- 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
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