Job Title: Regulatory Specialist I
Location: South Portland, ME 04106 (On-site role)
Duration: 12 months, with possible extension
Shift: 8.00 AM to 4:30 PM (Monday to Friday)
Years of Experience: 0-2 years of regulatory experience and/or relevant industrial experience, typically with a quality, product-development/support, or scientific affairs function
Responsibilities:- 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.
- Assists in developing internal procedures and tools.
- Carries out duties in compliance with established business policies.
- Demonstrates commitment to the development, implementation and effectiveness of Client Quality Management System per ISO, FDA, and other regulatory agencies.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company s policies and practices.
Basic qualifications | education:
Bachelor s Degree in Biology, Chemistry, Biochemistry, Engineering or other related
technical field or the equivalent combination of education and experience.
Competencies:- Knowledge of Federal Regulations
- Demonstrated written and verbal communication skills
- Strong time management skills, with the ability to work on multiple projects
- simultaneously
- Ability to work independently as well as within a team
- Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio