Regulatory & Documentation Specialist

Job overview

The Regulatory & Documentation Specialist role is based in Oak Brook, IL, with a hybrid option potentially available after the first 90 days. Pay is $80,000–$86,000 per year. The role supports regulatory affairs and compliance for Blistex’s over-the-counter pharmaceutical products.

What you'll do

• Maintain the company change-control system
• review product labeling and specifications for regulatory compliance
• use FDA monographs and other regulations to develop Drug Facts information
• monitor regulatory activity and advise on internal programs
• maintain facility licenses and drug listings
• support master records, international product dossiers, audits, and new product submissions
• and respond to regulatory questions.

What we're looking for

Skills & competencies

regulatory & documentation specialist

full-time

oak brook il

hybrid potential

blistex

regulatory affairs

otc pharmaceuticals

fda regulations

drug facts

change control

cgmp

$80k–$86k

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical coverage, insurance, financial benefits, and potential discretionary bonus.

Why this role

The posting seeks a relevant scientific degree and applicable quality assurance or regulatory affairs experience. A discretionary bonus may be part of total compensation; benefits include medical coverage, insurance, and financial benefits.

About the employer

Blistex Inc is hiring for this role. Industry: Pharmaceutical Preparation Manufacturing. Sector: 32.