Regulatory & Documentation Lead - OTC Compliance

Blistex Inc.; Oak Brook (IL); On-site; USD 80,000 - 86,000; Full time

Benefits offered by this job

Medical coverage

Insurance benefits

Bonus potential

Job summary

Blistex Inc. in Oak Brook, IL is seeking a Regulatory & Documentation Specialist to oversee regulatory affairs and compliance for OTC products under FDA guidelines. The role focuses on maintaining change control, labeling reviews, and compiling Drug Facts Box information.

You will coordinate with R&D, QA, and international partners, prepare registration dossiers, and support audits and submissions to meet global regulatory standards. A strong background in cGMP and documentation is essential.

Qualifications

• Bachelor's degree in Chemistry, Biology, or related scientific discipline with QA experience.
• Master's degree in Regulatory/Quality with related QA or regulatory experience.
• Demonstrates high standards of ethics and compliance; creates culture of trust.
• Excellent written and oral communication in business English.

Responsibilities

• Administers and maintains the Change Control System for compliance documentation.
• Reviews and evaluates product labeling for regulatory compliance.
• Develops Drug Facts Box information per FDA monographs and regulations.
• Develops country-specific ingredient lists using international guidance.
• Maintains facility licenses and drug listings; supports master records documentation.

Skills

Attention to detail

Analytical thinking

Effective communication

Regulatory knowledge

FDA regulations

Document control

Quality Assurance

Education

Bachelor's in Chemistry/Biology/related

Master's in Regulatory/Quality

Tools

MS Word

MS Excel

MS Outlook

Job description

Blistex Inc. in Oak Brook, IL is seeking a Regulatory & Documentation Specialist to oversee regulatory affairs and compliance for OTC products under FDA guidelines. The role focuses on maintaining change control, labeling reviews, and compiling Drug Facts Box information.

You will coordinate with R&D, QA, and international partners, prepare registration dossiers, and support audits and submissions to meet global regulatory standards. A strong background in cGMP and documentation is essential.