Regulatory Affairs Associate II_CMC_35181

K3 is seeking an experienced Regulatory Affairs Associate II to support CMC Regulatory Affairs activities for a leading pharmaceutical organization. This is an excellent opportunity for a regulatory professional with experience supporting CMC submissions, post-approval changes, and cross-functional teams.

📍 Location: North Chicago, IL – Hybrid (AP50, 1 N Waukegan Road)

⏳ Contract: 2 years

💼 Experience Level: 3–5 years

🎓 Education: Bachelor’s degree required

🔬 What You’ll Do

• Work with technical teams to prepare CMC regulatory filing dossiers
• Support preparation of regulatory submissions, including INDs/CTAs, amendments, new applications, supplements, renewals, annual reports, and variations
• Assess manufacturing and other changes for regulatory impact
• Support product lifecycle management and change control
• Analyze and interpret information that impacts regulatory decisions
• Review and revise submissions to effectively communicate data and regulatory strategy
• Respond to global regulatory information requests
• Support US/EU post-approval variation activities
• Participate in Global Regulatory Product Teams (GRPTs) and Operations Brand Teams as needed
• Manage responsibilities related to regulatory/document management systems
• Stay current with regulatory procedures, legislation, and changes in the regulatory environment
• Collaborate with Regulatory Affairs, Operations, R&D, Manufacturing, and other cross-functional partners

🎯 What We’re Looking For

Required:

• Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, Engineering, or a related discipline
• 2–4 years of CMC Regulatory experience
• Approximately 4 years of pharmaceutical or industry-related experience
• Experience in quality systems or cross-functional project management
• Strong written and verbal communication skills
• Ability to work effectively in a complex, matrixed environment

Preferred:

• Experience with US/EU post-approval variations
• Change management experience
• Experience developing or supporting international regulatory strategies for marketed products
• Advanced degree preferred; certification is a plus
• Regulatory Affairs experience and/or experience in Discovery, R&D, or Manufacturing

🌟 Ideal Candidate: A regulatory professional who understands CMC activities and can collaborate effectively with technical and cross-functional teams to support successful regulatory submissions and product lifecycle activities.

📩 Interested? Send your resume to K3 or reach out directly to learn more about this opportunity.

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