Regulatory Support Specialist

Job Description

Job Description

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.