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Regulatory Affairs

Regulatory Affairs

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Regulatory Affairs

  • Location:

    New Jersey

  • Sector:

    Regulatory Affairs - Pharma

  • Contact:

    Harry Reeve

  • Salary:

    US$15 - US$25 per hour

  • Job type:

    Interim/Contract

  • Contact email:

    harry.reeve@msipharma.com

  • Job ref:

    VR/04088_1655199767

  • Published:

    20 days ago

  • Duration:

    12 Months

  • Startdate:

    ASAP

  • Interacts with complainants and obtains essential information required to document technical complaints
  • Provides customer service and support to meet the needs of the complainants
  • Evaluates complaints for severity and risk to public safety.
  • Monitors and tracks sample receipt from critical complaints.
  • Prioritizes complaints for data entry and processing into the department PTC database.
  • Utilizes the customer service database to oversee complaint identification and processing.
  • Monitors complaint activity for assigned manufacturing sites.
  • Interacts with both internal and external manufacturing sites regarding technical complaints and their associated investigations.
  • Understands FDA complaint regulations for drug products and medical devices.
  • Performs file review and administrative closure for individual complaints.
  • Monitors open complaint activity for each manufacturing site.
  • Identifies and reports adverse events within one business day to Pharmacovigilance.
  • Participates on ad-hoc teams regarding product-specific complaint issues.
  • Supports Product Quality Complaint Managers/Director during FDA, regulatory, third party, and internal audits.
  • Understands product specific information regarding common product complaints.
  • Provides feedback to customers regarding complaint investigations.