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Sr. Regulatory Affairs Associate

Company: ADMA Biologics
Location: Boca Raton
Posted on: November 22, 2021

Job Description:

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Regulatory Affairs Sr. Associate! The Regulatory Affairs Sr. Associate, will manage and participates in the planning, organizing and interpreting of regulatory documents for submission to governmental regulatory agencies.QualificationsResponsibilities:

  • Maintain IND's and BLA's for various products; prepare and submit annual reports and final clinical reports to appropriate agencies.
    • Manage the preparation and submission of IND's, BLA's, CTD's, NDA's and OD's to regulatory agencies, etc.
      • Manage the lifecycle of BLA and IND sections.
        • Serve in advisory role to project teams regarding regulatory requirements and strategy development; keep management and team members abreast of project status and adherence to project deadlines.
          • Review and interpret industry-related regulations and guidance's (both US and foreign) to serve as informational resource where needed.
            • Ensure corporate policies and procedures are in full compliance with regulatory requirements and are being followed.
              • Serve as liaison with other company personnel, corporate partners and regulatory agencies to assist the project in staying on track and moving forward.
                • Asses and approve internal quality systems to ensure compliance with applicable applications and FDA regulations. Education Requirements: Bachelor's Degree in health or science-related field. Experience Requirements: At least five years of practical science or regulatory experience. In addition to competitive compensation, we offer a comprehensive benefits package including:
                  • 401K plan with employer match and immediate vesting
                  • Medical, Vision, Life and Dental Insurance
                  • Pet Insurance
                  • Company paid STD and LTD
                  • Company Paid Holidays and Personal Days
                  • 3 Weeks' Paid Time Off (within the first year)
                  • Tuition Assistance (after the first year)
                  • Easily accessible to Tri-Rail
                  • Company paid shuttle to the Boca Tri-Rail station ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit ADMA Biologics is an Equal Opportunity Employer.

Keywords: ADMA Biologics, Boca Raton , Sr. Regulatory Affairs Associate, Other , Boca Raton, Florida

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