Staff Regulatory Affairs Specialist (Pharmaceutical Products)

This is a hybrid role based in Cary, IL.

About the role

Provide information used to evaluate proposed products for regulatory classification and jurisdiction. Research requirements (local, national, international), applicable guidance and standards, and options for regulatory submissions, approval pathways, and compliance activities.

Responsibilities

• Prepare and author annual reports and other regulatory submissions required for approved pharmaceutical products.
• Assess product, process, and manufacturing changes to determine appropriate regulatory reporting requirements and submission pathways.
• Develop and submit amendments, supplements, and other regulatory filings in accordance with applicable regulations and guidance.
• Review technical documentation and regulatory content to ensure accuracy, completeness, and submission readiness.
• Research regulatory requirements, standards, guidance documents, and approval pathways to support product development and lifecycle management.
• Communicate with regulatory agencies regarding submission strategies, regulatory pathways, submission status, and responses to agency inquiries.
• Partner with engineering, quality, clinical, manufacturing, and marketing teams to support regulatory objectives during product development and sustaining activities.
• Develop and communicate regulatory guidance, requirements, and compliance considerations to support business and project goals.

Requirements

• Bachelor’s degree in Science, Engineering, Regulatory Affairs, or a related discipline.
• Minimum 4 years of experience in an FDA-regulated or other highly regulated industry.
• Minimum 2 years of Regulatory Affairs experience within the medical device and/or pharmaceutical industry.
• Experience reviewing regulatory requirements and assessing regulatory impact of product, process, or manufacturing changes.
• Experience preparing, authoring, or supporting drug regulatory submissions, including submissions for product approvals, post-approval changes, or lifecycle management activities.

Preferred Qualifications

• Regulatory Affairs Certification (RAC) or Master’s degree in Regulatory Affairs or a related field.
• Experience preparing or supporting international regulatory submissions and registrations.
• Experience interacting directly with regulatory agencies.

Pay

US10: $105,300 - $175,500 USD Annual

Benefits

• Health benefits: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program, and tobacco cessation program.
• Financial benefits: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.