CMC Regulatory Affairs Associate II — Hybrid Strategy & Submissions

Orion Group; North Chicago (IL); Hybrid; USD 94,558,000 - 111,751,000; Full time

Job summary

Orion Group in North Chicago, IL, is seeking a Regulatory Affairs Associate II to support CMC regulatory strategy and lifecycle management for marketed and development-stage products. You will work with internal and external partners to prepare regulatory strategies and submissions.

The role involves drafting CMC filing dossiers, managing submissions (INDs, CTAs, renewals, annual reports), and ensuring compliant documentation within a matrix environment; hybrid work is preferred.

Qualifications

• Bachelor's degree in chemistry, biology, pharmacy, pharmacology, engineering, or related discipline.
• 2-4 years of CMC regulatory experience; advanced degree preferred.
• 4 years of pharmaceutical or related industry experience.
• 1-2 years of experience in quality systems or cross-functional project management.
• Experience in a complex matrix environment.
• Strong written and verbal communication skills.

Responsibilities

• Prepare CMC regulatory filing dossiers with technical teams.
• Prepare CMC regulatory submissions including INDs/CTAs, amendments, new market applications, renewals, annual reports, supplements, and post-approval variations.
• Develop and manage content strategy for regulatory submissions.
• Assess regulatory impact of manufacturing and product changes; support change-control activities.
• Analyze information affecting regulatory decisions; seek expert advice as needed.
• Review and revise submission content to present data and strategy clearly.
• Respond to global regulatory information requests and escalate issues to management.
• Perform document management system responsibilities and maintain regulatory documentation.
• Build and maintain relationships across Regulatory Affairs, Operations, and R&D.
• Represent CMC Regulatory Affairs on product development and lifecycle-management teams.
• Stay current on regulatory procedures, legislation, and developments affecting the assigned business area.

Skills

CMC regulatory experience

Regulatory strategy

Communication skills

Education

Bachelor's degree in chemistry, biology, pharmacy, pharmacology, engineering, or related discipline

Job description

Orion Group in North Chicago, IL, is seeking a Regulatory Affairs Associate II to support CMC regulatory strategy and lifecycle management for marketed and development-stage products. You will work with internal and external partners to prepare regulatory strategies and submissions.

The role involves drafting CMC filing dossiers, managing submissions (INDs, CTAs, renewals, annual reports), and ensuring compliant documentation within a matrix environment; hybrid work is preferred.