Regulatory Specialist

We're Hiring: Regulatory Specialist I

Location: South Portland, Maine 04106 (On-site role)

Duration: 12 months (possible extension)

Work Schedule: Monday–Friday, 8:00 AM–4:30 PM

Job Overview

We are seeking a detail-oriented Regulatory Specialist I to support regulatory submissions, product compliance, licensing activities, and regulatory documentation. The ideal candidate will have 0–2 years of regulatory or relevant industry experience in quality, product development/support, or scientific affairs.

Key Responsibilities

• Compile and publish documentation required for regulatory submissions, license renewals, and annual registrations.
• Research scientific and regulatory information to support the preparation of submission documents.
• Maintain approvals, licenses, and authorizations for existing marketing authorizations.
• Ensure compliant product shipments by maintaining applicable regulatory records and spreadsheets.
• Update and maintain information in the Global Regulatory Information Database.
• Assess product, manufacturing, and labeling changes for regulatory reporting requirements and compliance.
• Organize and maintain electronic and physical departmental records.
• Stay informed about global regulatory requirements and updates.
• Assist in developing internal procedures, processes, and tools.
• Perform duties in accordance with established business policies and procedures.
• Support the effectiveness of the Quality Management System in alignment with applicable ISO standards, FDA requirements, and other regulatory guidelines.
• Maintain professional communication and positive working relationships with internal and external stakeholders.

Education & Experience

• Bachelor's degree in Biology, Chemistry, Biochemistry, Engineering, or a related technical field, or an equivalent combination of education and experience.
• 0–2 years of regulatory experience and/or relevant industry experience.

Required Skills & Competencies

• Knowledge of federal regulations.
• Strong written and verbal communication skills.
• Excellent time management and organizational abilities.
• Ability to manage multiple projects simultaneously.
• Ability to work independently and collaboratively within a team.
• Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Visio.

📩 Interested or know someone who would be a great fit? Apply today or send a message for more details!

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