Important COVID-19 Information - Click Here

Regulatory Specialist

Regulatory Specialist

Regulatory Specialist

Accentuate Staffing is recruiting for a Regulatory Specialist to join a Life Sciences company in Cary. This position is responsible for organizational functions related to domestic product registration and regulatory oversight of assigned products, projects, and technologies.

Responsibilities:

  • Responsible for Free-of-Charge material requests, tracking, shipping and follow up with requester to give tracking confirmation
  • Prepare and/or review regulatory submissions for assigned domestic or international projects.
  • Responsible for pulling Sales Tax by County report to process monthly, quarterly, semi-annual and annual tonnage reporting and mill assessments, including payments and recordkeeping
  • Responsible for proofing product and specimen label graphics sent to and from the Graphic Artist and/or Printer
  • Responsible for verifying the Specimen labels are most current on company website and printer portal
  • Use Custom Quick Label software to add labels to in-house printer for on-demand printing for operations
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Maintain electronic catalog of MSDS/SDS for manufacturing and laboratory
  • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
  • Determine the types of regulatory submissions or internal documentation that are required in situations such as labeling or MSDS/SDS changes, heavy metal analysis documentation, etc.
  • Prepare or maintain regulatory files as necessary to obtain and sustain product approval.
  • Actively participate as directed in the preparation of regulatory documents or submissions.
  • Prepare additional information or responses as directed or requested by regulatory agencies.
  • Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  • Attend and actively participate in relevant industry associations (ex., AAPFCO)

Requirements:

 

  • BA or BS degree in agriculture, biology, chemistry, or related scientific discipline and/or a minimum of 1 years related experience in regulatory affairs.
  • Experience with developing / documenting procedures
  • Computer proficiency (MS Word, Excel, PowerPoint)

Coronavirus (COVID-19) Information

You will find some resources regarding COVID-19 below: