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Regulatory Compliance Specialist

2 months ago

Boca Raton, Florida, United States Brightpath Associates LLC Full time
Job Description

At Brightpath Associates LLC, we are seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of our organization, you will play a critical role in ensuring our compliance with GxP regulations.

Key Responsibilities:

  • Compliance Oversight: Provide GxP compliance oversight for the organization, ensuring adherence to regulatory requirements.
  • Audit and Monitoring: Execute and manage paper, field, and program auditing and monitoring activities to ensure compliance.
  • Record Maintenance: Maintain audit files, evidence, and other records to support compliance efforts.
  • Reporting: Prepare timely, accurate, and complete reports with corrective action recommendations and follow-through with key stakeholders for implementation.
  • Compliance Program Management: Assist in the development, preparation, and management of periodic reporting of results to senior management.
  • Policy and Procedure Maintenance: Assist in the maintenance of compliance program, including, but not limited to, the company's commercial compliance policies and procedures.
  • Regulatory Compliance: Ensure compliance with internal policies, standards and procedures and external laws and regulations including environmental health and safety programs for the company.
  • Regulatory Monitoring: Monitor all state and federal regulations affecting pharmaceutical personnel and report on upcoming changes in federal and/or state laws.
  • Compliance Inspections: Prepare and conduct regular compliance inspections to ensure adherence to regulatory requirements.
  • Compliance System Effectiveness: Monitor compliance systems to ensure their effectiveness.
  • Internal Communications: Compose and disseminate standardized internal communications to personnel on important compliance developments, company policies, and procedures.
  • Investigation and Support: Assist with investigation of alleged violations of compliance policies, laws, regulations, or procedures.
  • GAP Analysis: Ensure adequate GAP Analyses are performed for new/revised Corporate and Division documents. Implement changes as appropriate.
  • Regulatory Inspections: Assist with all state, federal & regulatory inspections and information requests.
  • Compliance Training: Assist in the preparation of compliance training for company employees.
  • Continuous Improvement: Actively participates in continuous improvement programs to align with business strategies.
  • Regulatory Trends: Remain current with emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance.

Requirements:

  • Education: Bachelor's degree in science, engineering, quality or another technical field or high school diploma with a minimum of 4 years of experience is required.
  • Experience: A minimum of four years of experience in the pharmaceutical/biotechnology industry or other highly regulated industry.