What are the responsibilities and job description for the Regulatory Specialist position at ProKatchers LLC?
Job Title: Regulatory Specialist I
Location: South Portland, ME 04106
Duration: 12 months
Job Description:
- Compiles and publishes all material required for submissions, license renewals, and annual registrations.
- Assists in the research of scientific and regulatory information in order to write submission documents.
- Maintains approvals/licenses/authorizations for existing marketing authorizations.
- Ensures compliant shipment of products through the maintenance of applicable inclusions, spreadsheets, etc.
- Adds and maintains information contained in the Global Regulatory Information Database.
- Assesses product, manufacturing and labeling changes for regulatory reporting impact and compliance to regulations.
- Organizes and maintains hard copy and electronic department files.
- Keeps informed of global regulatory information.
- Demonstrates commitment to the development, implementation and effectiveness of Client's Quality Management Systems per ISO, FDA, and other regulatory agencies.
- Bachelor’s Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.