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    Director/Assoc Director Regulatory Affairs - Boston, United States - Apex Systems

    Apex Systems
    Apex Systems Boston, United States

    3 weeks ago

    Apex Systems background
    Full time
    Description

    Job#:

    Job Description:

    Associate Director/Director, Regulatory Affairs
    Location: Boston, MA(Remote)
    Therapeutic Areas : Neuro
    Job Overview: The Associate Director/Director will develop and implement global regulatory strategies, serving as the regulatory lead for clinical studies and obtaining necessary approvals for initiation, amendments, and maintenance activities in a collaborative team environment.
    Primary Job Responsibilities:
  • Collaborate as the Regulatory lead on project/clinical study teams to provide input on documentation and procedural requirements set by Regulatory Authorities, including submission delivery strategy, document reviews, and analysis of development procedures.
  • Coordinate regulatory submissions by working with business partners, external experts, CROs, and internal colleagues, and create, review, and edit submissions to support development efforts such as IND submissions and Clinical Trial Applications.
  • Lead multidisciplinary teams in preparing responses to Regulatory Agency questions during the review phases, and ensure proper planning, tracking, and alignment of contents and timelines for regulatory submissions across assigned indications and compounds.
    • Primary Job Requirements:
  • Bachelors, Masters, or PhD degree in a scientific or medical discipline and possess at least 5 years of experience in Regulatory Affairs within the pharmaceutical, biotechnology, CRO, or related industry.
  • Additional Skills, licenses, or certifications in Regulatory Affairs, with Regulatory Affairs Certification (RAC) being highly desirable.
  • Demonstrated hands-on experience in managing and preparing regulatory submissions, particularly Clinical Trial Applications outside of North America, with a focus on European applications using the Clinical Trials Information System (CTIS).
  • Exhibit a proven track record of successful clinical trial submissions in Canada, US, and Europe, coupled with a strong competency in understanding global regulatory requirements and evolving regulatory landscape.
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