• location: Cambridge, MA
  • type: Contract
  • salary: $35.37 - $41.62 per hour


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Job Title: Regulatory Affairs Specialist III

Job Summary

Management and conduct of the Global regulatory activities for assigned projects in line with regulatory requirements

Position Responsibilities

  • Provide Global Regulatory Strategyl support as needed on development and marketed products. This support will include both strategic and operational activities.
  • Preparing, compiling, reviewing and processing the regulatory submissions including both pre-approval and submissions such as IND, NDA/BLA, MAA, amendments/supplements, annual reports, study protocols, study reports, investigator brochures, safety 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.
  • Attending and participating in the assigned project/regulatory product development and submission teams, providing clear and consistent regulatory recommendations.
  • Assist with regulatory communications with the FDA for assigned products and activities, including preparing the 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
  • Coordinate required documentation in coordination with CMC Team or Functional group
  • Creating timelines and tracking deliverables to timelines to ensure that all submissions are submitted on-time
  • Interfacing with global Regulatory partners and internal cross functional teams
  • Attending relevant functional area and project team meetings as required

Education & Qualifications

  • BS minimum, Master of Science preferred
  • NDA, BLA/IND/CTA experience


  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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