Regulatory Affairs Specialist: Average Salary in Chicago, IL in 2024

Represent international RA and demonstrate leadership in complex product development strategies by identifying and interpreting relevant regulatory requirements, and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission. Review protocols and...

Staff International Regulatory Affairs Specialist. Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team. Tracks the status of applications under regulatory review and provides updates to the regulatory team. Medical Device Regulatory Affairs experience required. ...

The SEVIS Compliance Analyst is responsible for applying federal regulatory parameters to determine whether non-immigrant student and exchange faculty members are compliant with Department of Homeland Security (DHS) regulations, as part of the mandatory SEVIS reporting responsibilities of the Univer...

Plans, develops and prepares all required regulatory documents, including all initial, amendments and continuing reviews to the IRB, FDA, Office for Human Resource Protections (OHRP), and other regulatory bodies, including central offices of cooperative group studies, and sponsors where necessary. I...

All resumes submitted by search firms to any employee at Wounded Warrior Project via email, the Internet or directly to hiring managers at Wounded Warrior Project in any form without a valid written search agreement in place will be deemed the sole property of Wounded Warrior Project, and no fee wil...

The Regulatory Affairs CMC Manager / Sr. Manager is responsible for the on-time filing of high-quality regulatory submissions and for the post-approval maintenance of regulatory dossiers with an emphasis on CMC. Serve as the primary regulatory interface with US FDA manufacturing partners (domestic a...

Coordinates and monitors projects using a combination of internal staff, consultants, and vendors from initiation through delivery. Ensures completion of all project targets and requirements on schedule and within budget. Coordinate and manage projects throughout the lifecycle including design, deve...

Develop and report on KPIs for each project (delivery and performance) across the planning team, including business outcomes from each project such as service level improvements, process simplification, technology adoption, efficiency, and savings. Utilize Program and Project governance systems, inc...

The Senior Director/Director of Regulatory Affairs, Biopharma, will provide regulatory guidance for (Bio)Pharma product development and tech transfer, especially biosimilars. The successful candidate will develop regulatory strategies for projects and portfolios in BioPharma, contributing to the tra...

The IT Program Manager leads IT projects, ensuring they stay within scope and are completed successfully. Supervise, motivate and mentor cross-functional /cross divisional project team of project managers, business analysts, developers, and validation analysts. ...

This role, which reports to the company’s Executive Vice President of Regulatory Strategy & Government Affairs, focuses on public and regulatory affairs at the state and local level across our national footprint. This position will work cross-functionally with the compliance, legal, corporate commun...

The new Global Regulatory Affairs Director is a critical hire to this organization leading PMA regulatory negotiations as the FDA point person as well as guiding clinical affairs, quality management, R&D, and all company team leaders toward successful pre-market approval. In collaboration with the V...

Hallstar is committed to high standards of quality that ensure our products can be safely produced, handled, and used throughout the global regulatory landscape. We are also committed to providing accurate information for product safety and regulatory purposes, and to the health and safety of our em...

The Director, Regulatory Affairs is responsible for assisting with establishing and managing regulatory strategies, life cycle plans, and pre/post regulatory approvals. Comprehensive knowledge of current US and ex-US regulatory guidelines, in-depth experience leading Regulatory in Global environment...

Lead the US & Canada Regulatory team to prepare the documentation and submissions for FDA and Health Canada, as well as the responses to regulatory agencies. Responsible for the ongoing reviewing of regulatory materials for accuracy, comprehensiveness, and compliance with regulatory standards. Regul...

Support key information with prioritizing compliance stories, defects, and requirements in the shared backlog related to compliance. Coordinates and conducts the assessment of internal controls to ensure compliance as required by regulatory commissions/authorities. Ensure the organization's complian...

As the Director of Regulatory Affairs, you will be responsible for building and maintaining a global regulatory team, collaborating with quality, sourcing, marketing, R&D, and other functions to ensure our products are of the highest quality and compliant with all regulations. Director of Regulatory...

Regulatory Affairs Senior Manager is responsible for leading the regulatory strategy and managing the regulatory compliance in Personal Care and Cosmetics. This position will report directly to the Global Director Regulatory Affairs. Lead and enhance the regulatory program to enable the business wit...

Specialist, Capital Markets Compliance. Specialist, Capital Markets Compliance. Supports the completion of the Compliance Risk Assessment, which captures business processes and controls, and identifies control weaknesses that may be actual or potential compliance issues. Primarily focused on North A...

Partner with the EFCC Financial Intelligence Unit (FIU) leadership team and across EFCC to ensure the successful creation, implementation, and maintenance of effective transaction monitoring, list screening, and analytics programs. Department of Homeland Security E-Verify program in all facilities l...

Gather, analyze and document requirements for system changes working closely with Product Filing & Compliance Analyst and Executive Underwriting. Collaborate with IT Business Analyst for system changes and testing. Outline Compliance system changes for release notes to end users. Monitor product...

We focus on defining our clients' transformation roadmaps, identifying value opportunities, shaping our clients processes and solutions, and leading large complex business transformation programs enabled by SAP technologies. Set up and lead effective governance and program management office processe...

The NTAM Regulatory Relations Specialist is a new key role that will have accountability for fostering trusted working relationships with the firm's key regulators. Primary areas of focus include regular strategic communications and presentations, managing responses to regulatory findings, and coord...

Under the supervision of attorneys, the Corporate Compliance Specialist will provide support in all areas of Corporate Compliance including preparation of Annual Reports and Franchise Tax return filings. Kilpatrick, a large international law firm, is seeking a Corporate Compliance Specialist for our...

The Compliance Specialist will coordinate research compliance activities at the University's lakeside campuses to ensure regulatory compliance in human subjects research and animal research. Compliance with the regulations requires administrative support of the chairperson of the Institutional Revie...