• Director, Regulatory Affairs

    Job Locations US-MA-Bedford
    ID
    2019-1062
    Category
    Regulatory
    Type
    Full Time Salary
  • Overview

    Homology Medicines is currently searching for a Director, Regulatory Affairs to support activities required to progress our novel therapeutic programs through preclinical and clinical development and to ensure alignment within the company and regulatory agencies. This individual will be responsible for representing Regulatory Affairs in cross disciplinary areas and manage high-quality submissions to regulatory agencies. As Homology Medicines develops clinical assets, there could be additional duties and responsibilities to this role, including the expansion and management of additional team members. This position reports to the Vice President, Regulatory Affairs.

    Responsibilities

    • Represent Regulatory Affairs on project sub teams, especially Clinical and Nonclinical
    • Provide regulatory strategy and guidance for teams (e.g., protocol reviews, report reviews, development plans)
    • Responsible for preparing for regulatory agency meetings (e.g., INTERACT, Pre-IND, Type B & C, Pre NDA/MAA/NDS
    • Prepare regulatory submissions including INDs, CTAs, annual reports, NDAs, MAAs, briefing packages as well as orphan drug designation documents
    • Write regulatory documents to support regulatory submissions
    • Interacts with regulatory agencies
    • Develops and implements strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, etc.
    • Provides expertise in translating regulatory requirements into practical, workable plans.
    • Coordinate with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies
    • Establish and maintain Clinical Trials.gov postings for supported studies
    • Participate in regulatory intelligence gathering activities and maintain knowledge of US and EU regulatory requirements
    • Ensure compliance with regulatory requirements and timely preparation of organized and scientifically valid applications

    Qualifications

    • Ph.D preferred; Bachelor’s degree in life sciences required
    • Minimum of 10 years’ pharmaceutical industry experience with a minimum of 7 years in Regulatory Affairs
    • Experience with gene therapy development and CBER is a plus.
    • Evidence of successful submissions to FDA (e.g., INDs, briefing packages)
    • Demonstrated evidence of writing of regulatory documents (Module 1, Module 2, briefing packages)
    • Knowledge of FDA and ICH regulations and guidelines a must
    • Knowledge of drug development
    • Excellent written and oral communication skills
    • Excellent interpersonal skills
    • Strong project management skills and drive for excellence

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