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Regulatory Consultant - Strategic and Operational Support

Boston, MA

Posted: 01/20/2020 Employment Type: Contract Job Category: Clinical: Regulatory Job Number: 2424

Job Description

Our client is looking to add a Regulatory Consultant to their team on a contract basis. Length of contract: up to 6 months. The person in this role will provide strategic and operational support services to support ongoing commercialization activities.

  • Provide strategic and operational regulatory services to support ongoing US and global development and commercialization activities
  • Provide support for ex-US regulatory interactions, including orphan drug applications and MAA planning
  • Assist in the development and integration of regulatory and quality assurance processes for GXP compliance, including writing SOPs, document development, and archives
  • Ensure operations are compliant with FDA, ICH, EMA and industry standards
  • As needed, plan and/or lead regulatory meetings, make strategic contributions to clinical development plans, and coordinate with regulatory experts and consultants
  • Assist in developing support regulatory staff, if applicable
  • Regulatory Submissions
    • Maintain US regulatory applications and assist in the preparation and maintenance of global regulatory applications
    • Author, review and edit regulatory submissions
    • Provide project plans and timelines for regulatory submissions
    • Drive timelines and deliverables related to submission documents
    • Ensure QC checks of pending submissions
    • Understand electronic submission process and guide the development team in the preparation of electronic regulatory submissions, as needed
    • Assist in oversight of vendors responsible for electronic submissions
    • Assist in implementation of Electronic Document Management System
  • Regulatory Documentation
    • Author, review and/or edit documents i.e., informed consents, Investigator’ s Brochures, study materials, essential documents, presentations, and reports as necessary

Requirements / Qualifications:
  • Advanced degree with minimum of 15 years' industry experience, 8-10 years of direct regulatory experience and at least 5 years in a regulatory consulting role
  • Excellent working knowledge of drug development process and up-to-date knowledge of FDA regulatory requirements, regulations and guidelines
  • Strong familiarity with the global regulatory environment
  • Ability to provide strong regulatory leadership on a cross-functional team
  • Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development, including rare diseases

Meet Your Recruiter

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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