Regulatory Affairs Specialist III
Company: Integrated Resources, Inc
Posted on: November 22, 2021
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
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
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
Track regulatory project status and informational documents
Coordinate required documentation in coordination with CMC Team or
Creating timelines and tracking deliverables to timelines to ensure
that all submissions are submitted on-time
Interfacing with global Regulatory partners and internal cross
Attending relevant functional area and project team meetings as
BS in a scientific field minimum, Master of Science preferred
Minimum 1-2 years of pharmaceutical or biotechnology industry
experience, preferably in regulatory affairs
NDA/BLA or IND experience
Project Management Experience
Organized with attention to detail
Direct experience in Regulatory operations, coordinator
Experience with Veeva Vault preferred
Experience working with MS Word documents containing embedded
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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