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Regulatory Affairs Specialist III

Company: Integrated Resources, Inc
Location: Cambridge
Posted on: November 22, 2021

Job Description:

Job Description

Role can be remote or a hybrid of remote.

Job Duties and Responsibilities:
Management and conduct of the regulatory activities for assigned projects in line with regulatory requirements.
Provide Regulatory Strategy support as needed on development and marketed products.
Preparing, compiling, reviewing and processing the regulatory submissions including submissions such as IND, NDA/BLA, amendments/supplements, annual reports, study protocols, study reports, investigator brochures, 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 compiling of responses to the FDA queries.
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

Basic Qualifications:
BS in a scientific field minimum, Master of Science preferred
Minimum 1-2 years of pharmaceutical or biotechnology industry experience, preferably in regulatory affairs
Preferred Qualifications
NDA/BLA or IND experience
Project Management Experience
Regulatory Operations
Organized with attention to detail
Direct experience in Regulatory operations, coordinator
Experience with Veeva Vault preferred
Experience working with MS Word documents containing embedded macros preferred
Fundamental Knowledge to compare documents with FDA guidance documents and regulations

Keywords: Integrated Resources, Inc, Cambridge , Regulatory Affairs Specialist III, Other , Cambridge, Massachusetts

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