Regulatory Technician

Job Title 

Regulatory Technician  

Position Location 

Miramar FL  

Pay/hours for position 

$20 - $23/HR 

Requirements of position 

Education: 

Bachelor’s degree in life sciences, chemistry, pharmaceutical sciences, or a related field. 

Experience:  

1–3 years of experience in a GMP-regulated environment (pharmaceutical, biotechnology, food, or medical devices). 

Experience in regulatory affairs or quality assurance is a plus. 

Skills:  

Strong knowledge of GMP regulations (FDA 21 CFR Part 210/211, EU GMP, ICH Q7, etc.). 

Excellent attention to detail and organizational skills. 

Ability to work collaboratively across departments. 

Proficiency in Microsoft Office and document control systems. 

Job Summary: 

The Regulatory Technician (GMP) is responsible for supporting regulatory compliance activities within a GMP-regulated environment. This includes assisting in documentation control, reviewing procedures, ensuring compliance with regulatory requirements, and supporting audits and inspections. 

Key Responsibilities: 

Documentation & Compliance: 

Maintain and update GMP documentation, including standard operating procedures (SOPs), batch records, and technical files. 

Ensure all records comply with FDA, EMA, MHRA, or other relevant regulatory guidelines. 

Assist in reviewing and approving manufacturing and quality documents. 

Regulatory Support: 

Support regulatory submissions and product registration activities. 

Assist in preparing and compiling regulatory reports, summaries, and technical documents. 

Ensure compliance with cGMP, ICH guidelines, and company policies. 

Audit & Inspection Support: 

Assist in internal and external regulatory audits, including FDA, EMA, and other agency inspections. 

Help implement corrective and preventive actions (CAPA) based on audit findings. 

Quality & Risk Management: 

Monitor and report non-conformances and deviations. 

Support change control processes and risk assessments. 

Participate in GMP training programs and help maintain training records.