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Associate Director/Director, Regulatory Sciences

Company: System One
Location: Somerville
Posted on: January 8, 2022

Job Description:

Title: Associate Director/Director, Regulatory Sciences
Location: Bridgewater, NJ area
Duration: Direct Hire
Schedule: M-F Full Time
Target Start Date: ASAP


  • Regulatory Strategy, Agency Interaction and Submission Support
  • Provide regulatory expertise related to the design and implementation of strategies for the development of new drugs, biologics, medical devices and/or combination products (drug/drug or drug/device).
  • Provide regulatory guidance and submission strategy to clients based on FDA, EU, and ICH guidelines.
  • Direct interactions with FDA as US agent/regulatory agent for designated ex-US and US clients, respectively, serving as the primary FDA contact.
  • Develop and submit Sponsor Meeting Requests and Briefing Packages; facilitate meeting rehearsals and participate in meetings with FDA. As necessary, lead such FDA meetings.
  • Write or review documents, as applicable, and compile regulatory dossiers for submission to FDA and/or global health authorities, including but not limited to: IND, NDA, BLA, amendment, supplement, IMPD, DMF, etc.
  • Prepare and/or review and coordinate life cycle management submissions for all types of regulatory filings.
  • Project Management
    • Manage multiple projects - coordinate/discuss project specifics with clients; establish timelines for submissions; manage submission content plans; prepare or review documents for submission to regulatory agencies, as applicable.
    • Work with the team to ensure efficiency in submission process.
    • Leadership
      • Supervision of junior level team members, including performance feedback, mentoring, training, and interviewing
      • Direct strategic initiatives as a member of the Senior Leadership Team
      • Help maintain -workplace culture that emphasizes the strengths and values of the company processes and the integrity of submissions.
      • Business Development Support
        • Support business development activities and represent company to potential/new clients.
        • Prepare Statements of Work (SOWs). Requirements:
          • BS/BA in Regulatory Sciences or Life Sciences. RAC and/or MS/Ph.D. are a plus.
          • Knowledge of regulatory sciences as demonstrated through a combination of work experience and academic background:
          • Prior professional experience in pharma, bio tech, or medical devices companies -
          • Prior experience with regulatory submissions and interactions with the FDA or other Health Authorities.
          • Prior experience with eDRLS submissions.
          • Knowledge and experience with eCTD.
          • Interpret and apply regulations as they apply to specific project issues: 21 CFR, FDA, ICH, or other regulatory agency guidance requirements.
          • Experience in a consulting environment is a plus. Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

Keywords: System One, Somerville , Associate Director/Director, Regulatory Sciences, Executive , Somerville, Massachusetts

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