Associate Director Regulatory Affairs

2 weeks ago


Boca Raton, United States GL Staffing Full time

Our client is a is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection.

If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider to apply to this job. We currently have an exciting opportunity available for a Associate Director, Regulatory Affairs in Boca Raton, Fl.


The Associate Director, Regulatory Affairs - Plasma Services is responsible for the regulatory compliance of the Plasma Services Organization. Acts as the designated company authorized official for all communications with regulatory agencies regarding Plasma related issues. Supervises and participates in planning, preparing and evaluating regulatory documents for submission to the U.S. Food and Drug Administration (FDA). This position provides advice and direction regarding regulatory requirements.

  • Be a versatile regulatory affairs department team member and produce work-product commensurate with professionalism and of the highest quality standards to submit to regulatory authorities for review and approvals.
  • Provides regulatory affairs guidance and support to Plasma Operations, Center Management, and Plasma Corporate staff to ensure regulatory compliance by Center facilities and Plasma organization.
  • Reviews and interprets all applicable regulations governing Plasma processes and procedures to ensure full compliance.
  • Ensures Plasma Centers are in compliance with all applicable governing regulatory agencies, assists with documentation for inspections and audits, provides insight and guidance for regulatory reporting and follow up of any 483’s or other identified issues; recommend corrective and preventive actions as necessary.
  • Is available to regulatory authorities during inspections to ensure appropriate information is supplied as requested. Accompanies FDA inspectors for pre-scheduled new and routine center audits as directed.
  • Prepares submission of Biologics License Applications (BLA's) associated to center establishments and plasma products and CLIA/COLA licensing as related to Plasma Center operations as directed.
  • Prepares FDA Annual Report as it relates to the Plasma collection organization.
  • Assists and collaborates with Plasma QA and Plasma Operations in the crafting audit and inspection responses.
  • Provides regulatory affairs related consultation regarding Lookback, Post-Donation and Error/Accident, and BPDR situations as requested.
  • Works with Plasma QA to notify FDA of any recalls and follows up with the FDA, other applicable regulatory agencies and customers as required, in accordance with the regulations and applicable laws.
  • Aids in review from a regulatory affairs standpoint, of new and revised Plasma Center Standard Operating Procedures (SOP's), and review of related training materials with regard to applicable regulations to ensure compliance with applicable laws.
  • Makes regulatory decisions and recommendations as applicable and required in collaboration with Regulatory Affairs and appropriate company leadership and other departments.
  • Responsible for the preparation, review, presentation, and publishing of FDA submissions to assure accuracy and completeness of submission documents, which includes but is not limited to meeting requests/briefing packages and presentations to the FDA (e.g., preIND/pre-BLA, Type A,B or C, and advisory committee meetings), Investigational New Drug Applications (INDs), Biologic License Applications (BLAs), Marketing and Promotional Materials, Product Listing and Establishment License Applications, and other related documents or CMC supplement submissions as directed to support the company.
  • Develops regulatory strategies, determines submission requirements and requests necessary data, information, and documentation from pertinent departments and Subject Matter Experts (SMEs), as needed.
  • Assures supplements and amendments to BLAs are completed within specified regulatory timeframes. Reviews all materials to be included in submissions for accuracy and completeness, which include collection data, viral marker data, stability, validation and investigation reports, product and plasma unit testing data and information packages prepared by SMEs.
  • Oversees regulatory operations by tracking submissions and Post Marketing Requirements/Commitments. Appropriate knowledge of eCTD format and submission software systems.
  • Reviews and evaluates change controls and deviations to determine regulatory impact and reporting requirements. Evaluates, prepares and submits Biological Product Deviation Reports as necessary.
  • Advises Project Teams regarding regulatory requirements; serves as Project Team member to ensure primary and alternate strategies are appropriately explored.
  • Serves in advisory roles to plasma collection project teams (or others as directed) regarding regulatory requirements and strategy development; keeps management and team members abreast of regulatory affairs related project status and adherence to project deadlines.
  • Participates in company projects, project-based tasks and/or special projects as assigned by the Senior Director, Regulatory Affairs.
  • Additional duties related to supporting the needs of the business can be assigned by senior management as deemed necessary.


Education Requirements:

Bachelor’s degree in Pharmaceutical, Biological or Chemical Science or related field. Master’s degree preferred.


Experience Requirements:

A minimum of ten years of pharmaceutical regulatory experience in Plasma industry or related field with an emphasis on Biologics and BLA submission 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
  • 3 Weeks’ Paid Time Off (within the first year)
  • Tuition Assistance (after the first year)
  • Easily accessible to Tri-Rail
  • Free shuttle to the Boca Tri-Rail station



  • Boca Raton, United States GL Staffing Full time

    Our client is a is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider to apply to this job. We currently have an...


  • Boca Raton, United States ADMA BIOMANUFACTURING LLC Full time

    Job DetailsJob Location ADMA Biologics - Boca Raton, FL Travel Percentage Up to 50% Job Shift Day DescriptionADMA 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...


  • Boca Raton, United States elliquence Full time

    elliquence has a 50-year heritage of technological distinction and global presence in the fields of neurosurgery, endoscopic spine, orthopedic and pain management. Our vision has been to partner with the medical community and develop innovative, high quality, cost-effective products benefiting patients, physicians, and medical facilities. The RA Specialist...


  • Boca Raton, United States Elliquence Full time

    Job DescriptionJob Descriptionelliquence has a 50-year heritage of technological distinction and global presence in the fields of neurosurgery, endoscopic spine, orthopedic and pain management. Our vision has been to partner with the medical community and develop innovative, high quality, cost-effective products benefiting patients, physicians, and medical...


  • Boca Raton, United States elliquence Full time

    elliquence has a 50-year heritage of technological distinction and global presence in the fields of neurosurgery, endoscopic spine, orthopedic and pain management. Our vision has been to partner with the medical community and develop innovative, high quality, cost-effective products benefiting patients, physicians, and medical facilities. The RA Specialist...


  • Boca Raton, United States Elliquence Full time

    Job DescriptionJob Descriptionelliquence has a 50-year heritage of technological distinction and global presence in the fields of neurosurgery, endoscopic spine, orthopedic and pain management. Our vision has been to partner with the medical community and develop innovative, high quality, cost-effective products benefiting patients, physicians, and medical...


  • Boca Raton, United States Elliquence Full time

    Job DescriptionJob Descriptionelliquence has a 50-year heritage of technological distinction and global presence in the fields of neurosurgery, endoscopic spine, orthopedic and pain management. Our vision has been to partner with the medical community and develop innovative, high quality, cost-effective products benefiting patients, physicians, and medical...


  • Boca Raton, United States Elliquence Full time

    Job DescriptionJob Descriptionelliquence has a 50-year heritage of technological distinction and global presence in the fields of neurosurgery, endoscopic spine, orthopedic and pain management. Our vision has been to partner with the medical community and develop innovative, high quality, cost-effective products benefiting patients, physicians, and medical...


  • Boca Raton, United States Elliquence Full time

    Job DescriptionJob Descriptionelliquence has a 50-year heritage of technological distinction and global presence in the fields of neurosurgery, endoscopic spine, orthopedic and pain management. Our vision has been to partner with the medical community and develop innovative, high quality, cost-effective products benefiting patients, physicians, and medical...


  • Boca Raton, United States Florida Atlantic University Full time

    For more information on everything FAU has to offer, please visit Position Summary: Florida Atlantic University is seeking an Assistant Director of Student Services - Boca Raton, FL. The Assistant Director for Student Services is responsible for managing multiple ongoing diverse and complex student projects and events, establishing priorities, identifying...


  • Boca Raton, United States REDCON1 LLC Full time

    Job Title: Quality Control and Regulatory Compliance Manager Company: Redcon1 Location: Boca Raton, FL About Redcon1: REDCON1 is a mission-driven company founded on a simple principle: to create the highest quality supplements for individuals who need to get the most out of their workout and workday. Driven by a passion for excellence and a commitment to...


  • Boca Raton, United States REDCON1 Full time

    Job Title: Quality Control and Regulatory Compliance ManagerCompany: Redcon1Location: Boca Raton, FLAbout Redcon1: REDCON1 is a mission-driven company founded on a simple principle: to create the highest quality supplements for individuals who need to get the most out of their workout and workday. Driven by a passion for excellence and a commitment to...


  • Boca Raton, Florida, United States Financial Industry Regulatory Authority , Inc. Full time

    An Alternative Net Capital (ANC) Associate Principal Specialist conducts examinations to assess member firms' risk management frameworks and evaluate systems, procedures and internal controls established to effectively manage market, credit and liquidity risks. The role includes in-depth review, analysis, and testing of the of firms' books and records and...


  • Boca Raton, Florida, United States Financial Industry Regulatory Authority, Inc. Full time

    An Alternative Net Capital (ANC) Associate Principal Specialist conducts examinations to assess member firms' risk management frameworks and evaluate systems, procedures and internal controls established to effectively manage market, credit and liquidity risks. The role includes in-depth review, analysis, and testing of the of firms' books and records and...

  • Compliance Associate

    4 weeks ago


    Boca Raton, United States ADMA Biologics Inc Full time

    Job Details Job Location: ADMA Biologics - Boca Raton, FL Position Type: Full Time Education Level: 4 Year Degree Salary Range: Undisclosed 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...


  • Boca Raton, United States Florida Atlantic University Full time

    For more information on everything FAU has to offer, please visit Position Summary: Florida Atlantic University is seeking a Student Services Specialist - Boca Raton, FL. Summary of Responsibilities: Administrative Support - Assists the Assistant Dean of Student Affairs with the execution and continued growth of the Career Advising Program. - Schedule and...


  • Boca Raton, United States ADMA Biologics Inc Full time

    Job Details Job Location : ADMA Biologics - Boca Raton, FL Position Type : Full Time Education Level : 4 Year Degree Salary Range : Undisclosed 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...


  • Boca Raton, United States The University of Miami Full time

    Current Employees:If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.JOB DESCRIPTION: ASSOCIATE PROFESSOR OF CLINICAL AUDIOLOGY AND...


  • Boca Raton, United States Florida Atlantic University Full time

    For more information on everything FAU has to offer, please visit Position Summary: Florida Atlantic University is seeking an Assistant Director, Programs and Traditions - Boca Raton, FL Summary of Responsibilities: Administration and Supervision This team member will provide support to the Student Activities and Involvement Office and the overall...


  • Boca Raton, United States Finra Full time

    The Investigations Director, Specialist Team, manages examinations and investigations of broker-dealers’ compliance with applicable rules and regulations, and financial crimes. The Director develops and supervises specialists regulatory programs and work products related to the routine and special examinations/investigations and other reviews related to...