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Manager/Sr. Manager - US Regulatory Lead and Regulatory Operations

Skokie, IL 60077

Posted: 10/14/2025 Employment Type: Direct Hire Job Category: Regulatory Job Number: 4677

Job Description

You'll be responsible for ensuring compliance with regulatory standards while driving the US regulatory strategy for product(s)/project(s) ensuring there is sound regulatory foundation for the successful optimization of the product/project in accordance with business priorities. This role will work closely with the Head of Regulatory Affairs and cross-functional stakeholders (e.g., program management, clinical operations, clinical development, and technical operations) ensuring alignment on US strategy and compliance with regulatory requirements on product(s) and project(s).

Responsibilities:
  • Implement regulatory strategies for assigned products, considering US regulations and global requirements.
  • Identify and assess regulatory risks and develop mitigation strategies.
  • Ensure product compliance with applicable US regulations throughout the product lifecycle including authorship of routine regulatory correspondence (e.g. annual reports, investigator packages).
  • Identify and resolve issues affecting submission timelines; drive process efficiency and ensure high-quality, timely submissions.
  • Prepare and manage regulatory packages and submissions, including original and amendment filings for INDs. Coordinate collection of functional documents in support of regulatory applications.
  • Maintain regulatory and technical sections of CTD filings to ensure compliance and archives with current product information (applications, letters, etc.).
  • Collaborate with CROs/partners to support site initiation, as applicable.
  • Develop and maintain expertise in relevant US regulations and guidelines.
  • Support process improvement initiatives, standards development, and metrics for COUR Regulatory Information Management System.
Requirements/Qualifications:
  • Bachelor’s degree in a scientific discipline required.
  • 5-7+ years of progressively responsible experience in Regulatory Affairs.
  • Strong knowledge of regulatory business operations, budgeting, and vendor/contract management.
  • Proficient in Microsoft Excel and regulatory and contract management platforms; experience with Regulatory Information Management System preferred.
  • Competencies: Teamwork & Collaboration, Attention to Detail, Negotiation skills, Problem Solving, Organizational skills, Written and Verbal Communications
  • Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations.
  • This is a hybrid/remote role.
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About Skokie, IL

Ready to kickstart your career in Skokie, Illinois? This vibrant suburb of Chicago offers a perfect blend of urban amenities and suburban charm, making it an ideal place to grow both personally and professionally. From the delightful Skokie Farmers' Market to the world-renowned Skokie Sculpture Park, this area is brimming with cultural attractions and recreational opportunities. Discover the charm of Skokie's diverse dining scene, catch a performance at the Skokie Theatre, or explore the stunning collections at the Illinois Holocaust Museum & Education Center. With easy access to downtown Chicago and top-notch schools in the area, Skokie provides a perfect balance for both work and play. Explore our job listings in Skokie today and take the next step towards an exciting career in this bustling community.