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.
- 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)
- 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)