Regulatory Affairs Associate II (CMC Regulatory Strategy and Lifecycle Management)

Regulatory Affairs Associate II - CMC Regulatory Strategy and Lifecycle Management
Location: Hybrid - North Chicago, Illinois
Length of Assignment: 2 years
Pay Rate: 33-39/hr (depending on benefits preference and candidate location)

Job Description:
The Regulatory Affairs Associate II supports Chemistry Manufacturing and Controls regulatory activities for marketed and development-stage products. Working with internal and external partners, this role helps prepare regulatory strategies and submissions that support timely approvals and continued product availability.

• Work with technical teams to prepare CMC regulatory filing dossiers.
• Prepare CMC regulatory submissions under management supervision, including INDs and CTAs, amendments, new market applications, renewals, annual reports, supplements, and post-approval variations.
• Develop and manage content strategy for regulatory submissions under management supervision.
• Assess manufacturing and product changes for regulatory impact and support change-control activities in accordance with regulations and company policies.
• Analyze and interpret information that may affect regulatory decisions; seek expert advice and technical support as needed.
• Review and revise submission content to clearly present data and regulatory strategy to health authorities.
• Respond to global regulatory information requests under management supervision and promptly escalate important issues to regulatory management.
• Perform document management system responsibilities and maintain accurate regulatory documentation.
• Build and maintain relationships across Regulatory Affairs, Operations, and Research and Development organizations.
• Represent CMC Regulatory Affairs on product development and lifecycle-management teams, including Global Regulatory Product Teams and Operations Brand Teams, as needed.
• Stay current on regulatory procedures, legislation, and developments affecting the assigned business area.

Qualifications:

Required Qualifications:

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

Preferred Qualifications:

• Relevant advanced degree or professional certification.
• 5 years of pharmaceutical experience, including 1-2 years in Regulatory Affairs or 1-2 years in Discovery, Research and Development, or Manufacturing.
• Experience supporting United States and European Union post-approval variations.
• Change-management experience and experience developing international regulatory strategies for marketed products.
• Ability to work onsite in a hybrid arrangement; in-person availability is preferred.

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