Regulatory Affairs Specialist III (Clinical) in Cambridge, MA at Pyramid Consulting, Inc

Date Posted: 7/9/2020

Job Snapshot

Job Description

Immediate need for a Job title  Regulatory Affairs Specialist III (Clinical) experience in the Pharmaceutical Industry. This is 6+ Months Contract position for the location Cambridge, MA.  .Please review the job description below:

JOB ID # 20-17851

Job Description:
• 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.

Our client is a leading Pharmaceutical Organization and we are currently interviewing to fill this and other similar Contract positions. Qualified candidates should apply online for immediate consideration.