Regulatory Support Specialist

5th HQ -

We are seeking a detail-oriented and highly organized Regulatory Technician to join our team. This role is responsible for ensuring compliance with FDA regulations and maintaining regulatory documentation related to manufacturing, packaging, labeling, and holding operations for dietary supplements. The ideal candidate should have strong technical writing skills, regulatory knowledge, and experience in a cGMP-controlled environment.

Minimum Qualifications:

High school diploma required (Pharmaceutical or related industry experience preferred).
cGMP training and orientation programs completed (prior experience in cGMP manufacturing is a plus).
Strong technical writing and verbal communication skills. Ability to manage multiple tasks and meet deadlines.
Proficiency in MS Office (Word, Excel, PowerPoint) and ERP systems.

Key Responsibilities:

• Ensure compliance with FDA regulations (21 CFR Part 111) for manufacturing, packaging, labeling, and holding of dietary supplements.
• Manage accreditations, certifications, licenses, and permits from federal and international agencies.
• Review and determine regulatory compliance for all labeling and packaging components.
• Serve as Regulatory Intelligence by staying up to date on FDA regulations and industry practices.
• Prepare and maintain customer quality questionnaires.
• Keep management informed of new FDA regulations and industry developments.
• Work with department managers to coordinate updates to procedures and documentation.
• Maintain and ensure the safe storage and inventory of labels.
• Control the issuance and return of labels within the packaging department.
• Coordinate and implement GMP training programs and conduct sessions when necessary.
• Maintain all training documentation in accordance with company policies.
• Prepare technical submissions for international product registration.
• Oversee the status and maintenance of trademarks, registrations, and patents.
• Perform other duties as assigned by the immediate supervisor.