Regulatory Affairs Specialist III (Clinical)

Cambridge, MA 2142

Job Category: Healthcare-Other Job Number: 150789

Job Description

Job Title:               Regulatory Affairs Specialist III (Clinical)

Location:               Cambridge, Massachusetts, US

Job Type:               Contract

Duration:               6 Months With Possible Extension

Job Description:

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

Skills:

  • 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.

Education:

  • BS/BA in a scientific field

About ASK: ASK Staffing is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Staffing connects people with amazing opportunities

Reach Out To A Recruiter

Name:              Abhishek Siddharth

Email:              abhisheks@askstaffing.com

Phone:             678-890-4668

Meet Your Recruiter

Subhasis Sahu
Resource Specialist

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