62 regulatory affairs specialist jobs found

About The Job Regulatory Affairs Specialist 9791RF About The Job Join a team that sits at the heart of advancing clinical research at the University of Minnesota. The Regulatory Affairs Specialist is a trusted institution subject matter expert who ensures our studies meet the highest standards of compliance, preventing fines and inspection findings while helping investigators bring forward discoveries that can change lives. In this role, you’ll balance precision with collaboration, preparing FDA submissions, managing ClinicalTrials.gov records, and advising research teams across the institution. You’ll also contribute to process improvements that make regulatory compliance not only possible, but efficient and sustainable. The individual who will thrive in this role has a strong attention to detail, a drive to follow best practices, strong written and verbal communication skills, and a talent for rapid response times to tasks and inquiries....

Job Title: Regulatory Affairs Specialist Job Description The Regulatory Affairs Specialist plays a crucial role in supporting US FDA applications (NDAs, ANDAs, DMFs) and international drug product applications. This position involves planning, authoring, compiling, and submitting statutory reports in eCTD format for marketed products according to FDA requirements. The role also includes reviewing and assessing CMC regulatory impacts of post-approval changes and providing regulatory strategies. Responsibilities Plan, author, compile, and submit statutory reports in eCTD format for marketed products per FDA requirements. Review and assess CMC regulatory impact of post-approval changes proposed at the manufacturing site and provide regulatory strategy. Plan, author, compile, submit, and manage variations and supplements for marketed products within and outside the United States. Participate in cross-functional teams and provide health authority requirements needed for...

Ann & Robert H. Lurie Children’s Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H. Lurie Children’s Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report. Location Ann & Robert H. Lurie Children's Hospital of Chicago Job Description General Summary: Under the direction of Director, Regulatory and Quality Assurance within the Office of Research Integrity & Compliance this position serves as an essential resource within the Medical Center, providing technical expertise and regulatory guidance for the research community with a focus on the...

Summary The Lead Clinical Laboratory Scientist (CLS) communicates the organization's strategic plan, mission, vision, and values. The Lead CLS identifies, distributes,balances work, coaches, and facilitates with problem solving methods. Responsibilities Duties/Tasks - Serves as an expert providing authoritative advice and consultation for more markedly difficult, complex, unique, and/or emerging tests requiring special knowledge. Examples are, but not limited to, molecular/DNA testing, bone marrow examination, genetic testing, and flow cytometry. - Conducts studies and recommends changes to correct deficiencies and improve the specialty area. Recommends new/replacement instrumentation. - Designs workflow to accomplish objectives in the clinical specialty area. - Advises all organizational levels on various aspects of the specialized testing, including the appropriateness of specific tests and takes into consideration the clinical context and usefulness of the test information....

Job Description Insight Global is seeking a qualified Adverse Event Specialist to join an established medical device company in Mundelein, IL. This individual will be responsible for both product complaint remediation and processing new complaints for reportability. The role reviews historical and newly received complaints to determine MDR reportability in alignment with current procedures and regulatory requirements. It ensures that all MDR submissions are completed in full compliance with FDA reporting requirements, 21 CFR 803, and Quality System regulations. Responsibilities: Review new and historical product complaints to verify data completeness and ensure reportability decisions align with current regulatory standards, internal procedures, and decision trees. Evaluate new and historical complaint files to determine MDR reportability under 21 CFR 803, applying current criteria, definitions, and decision logic to reach a regulatory reporting decision. Work cross...

Vacancy Details Title Controller School/Building Oshkosh Area School District Central Office Number of Openings 1 URL N/A Close Date (11:59 p.m. Central) Open until filled Contact Name Drew Niehans Title Executive Director of Business Services Email Drew.Niehans@oshkosh.k12.wi.us Phone 920-424-0395 Position Details Position Start Date 7/1/2026 Salary/Wage $115,000 - $135,000 Annual Terms/Schedule 52 Weeks Appointment Type Full Time Description Position Summary: To assist the Executive Director of Business Services in managing the financial affairs of the district in accordance with the objectives and policies of the Board of Education, and in accordance with the Statutes of the State of Wisconsin. Essential Functions: 1. Responsible for all aspects of cash management including short-term cash flow...

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice. Associate Director Institutional Sales Specialist, Learning & Development As a leader in designing, developing, and deploying health systems Institutional Sales Specialist training, you will play a crucial role in empowering our CE teams. By leveraging your strong facilitation and platform skills, you will deliver training through both asynchronous and synchronous learning approaches. Your mission is...

Location : United States (remote work) Ability to Trave l: May require 25-50% travel Job Description: The Principal of U.S. Government Relations will be a seasoned government relations professional with direct experience in multi-state legislative and regulatory advocacy. The primary responsibility of this role will be to advocate for policies that support and advance Pearson’s postsecondary business objectives nationally, while also collaborating with other internal business leaders and teams on government relations initiatives in assigned states. This position will be responsible for legislative and regulatory activities that affect the business and will ensure stakeholders are kept informed and engaged through the development and execution of government relations strategies. The Principal will build and maintain relationships with government leaders, policymakers, regulators, industry stakeholders, and other external parties within the region and target markets. This...

Summary This position is eligible for the Education Debt Reduction Program (EDRP), a student loan payment reimbursement program. You must meet specific eligibility requirements per VHA policy and submit your EDRP application within four months of appointment. Program Approval, award amount (up to $200,000) & eligibility period (one to five years) are determined by the VHA Education Loan Repayment Services program office after review of the EDRP application. Former EDRP participants ineligible to apply. Responsibilities This position is located in the Pharmacy section at the Ralph H. Johnson VA Medical Center. A pharmacist in this assignment is responsible for covering in the Hematology and Oncology Clinic, Oral Chemotherapy clinic and Chemotherapy Clinic or any of the specialized areas of pharmacy related to Oncology. Major duties include, but are not limited to: Provides clinical coverage in the hematology/oncology clinic and other clinics as assigned. Medication Management:...

Location : United States (remote work) Ability to Trave l: May require 25-50% travel Job Description: The Principal of U.S. Government Relations will be a seasoned government relations professional with direct experience in multi-state legislative and regulatory advocacy. The primary responsibility of this role will be to advocate for policies that support and advance Pearson’s postsecondary business objectives nationally, while also collaborating with other internal business leaders and teams on government relations initiatives in assigned states. This position will be responsible for legislative and regulatory activities that affect the business and will ensure stakeholders are kept informed and engaged through the development and execution of government relations strategies. The Principal will build and maintain relationships with government leaders, policymakers, regulators, industry stakeholders, and other external parties within the region and target markets. This...

Location : United States (remote work) Ability to Trave l: May require 25-50% travel Job Description: The Principal of U.S. Government Relations will be a seasoned government relations professional with direct experience in multi-state legislative and regulatory advocacy. The primary responsibility of this role will be to advocate for policies that support and advance Pearson’s postsecondary business objectives nationally, while also collaborating with other internal business leaders and teams on government relations initiatives in assigned states. This position will be responsible for legislative and regulatory activities that affect the business and will ensure stakeholders are kept informed and engaged through the development and execution of government relations strategies. The Principal will build and maintain relationships with government leaders, policymakers, regulators, industry stakeholders, and other external parties within the region and target markets. This...

Location : United States (remote work) Ability to Trave l: May require 25-50% travel Job Description: The Principal of U.S. Government Relations will be a seasoned government relations professional with direct experience in multi-state legislative and regulatory advocacy. The primary responsibility of this role will be to advocate for policies that support and advance Pearson’s postsecondary business objectives nationally, while also collaborating with other internal business leaders and teams on government relations initiatives in assigned states. This position will be responsible for legislative and regulatory activities that affect the business and will ensure stakeholders are kept informed and engaged through the development and execution of government relations strategies. The Principal will build and maintain relationships with government leaders, policymakers, regulators, industry stakeholders, and other external parties within the region and target markets. This...

Location : United States (remote work) Ability to Trave l: May require 25-50% travel Job Description: The Principal of U.S. Government Relations will be a seasoned government relations professional with direct experience in multi-state legislative and regulatory advocacy. The primary responsibility of this role will be to advocate for policies that support and advance Pearson’s postsecondary business objectives nationally, while also collaborating with other internal business leaders and teams on government relations initiatives in assigned states. This position will be responsible for legislative and regulatory activities that affect the business and will ensure stakeholders are kept informed and engaged through the development and execution of government relations strategies. The Principal will build and maintain relationships with government leaders, policymakers, regulators, industry stakeholders, and other external parties within the region and target markets. This...

Location : United States (remote work) Ability to Trave l: May require 25-50% travel Job Description: The Principal of U.S. Government Relations will be a seasoned government relations professional with direct experience in multi-state legislative and regulatory advocacy. The primary responsibility of this role will be to advocate for policies that support and advance Pearson’s postsecondary business objectives nationally, while also collaborating with other internal business leaders and teams on government relations initiatives in assigned states. This position will be responsible for legislative and regulatory activities that affect the business and will ensure stakeholders are kept informed and engaged through the development and execution of government relations strategies. The Principal will build and maintain relationships with government leaders, policymakers, regulators, industry stakeholders, and other external parties within the region and target markets. This...

Location : United States (remote work) Ability to Trave l: May require 25-50% travel Job Description: The Principal of U.S. Government Relations will be a seasoned government relations professional with direct experience in multi-state legislative and regulatory advocacy. The primary responsibility of this role will be to advocate for policies that support and advance Pearson’s postsecondary business objectives nationally, while also collaborating with other internal business leaders and teams on government relations initiatives in assigned states. This position will be responsible for legislative and regulatory activities that affect the business and will ensure stakeholders are kept informed and engaged through the development and execution of government relations strategies. The Principal will build and maintain relationships with government leaders, policymakers, regulators, industry stakeholders, and other external parties within the region and target markets. This...

Location : United States (remote work) Ability to Trave l: May require 25-50% travel Job Description: The Principal of U.S. Government Relations will be a seasoned government relations professional with direct experience in multi-state legislative and regulatory advocacy. The primary responsibility of this role will be to advocate for policies that support and advance Pearson’s postsecondary business objectives nationally, while also collaborating with other internal business leaders and teams on government relations initiatives in assigned states. This position will be responsible for legislative and regulatory activities that affect the business and will ensure stakeholders are kept informed and engaged through the development and execution of government relations strategies. The Principal will build and maintain relationships with government leaders, policymakers, regulators, industry stakeholders, and other external parties within the region and target markets. This...

Location : United States (remote work) Ability to Trave l: May require 25-50% travel Job Description: The Principal of U.S. Government Relations will be a seasoned government relations professional with direct experience in multi-state legislative and regulatory advocacy. The primary responsibility of this role will be to advocate for policies that support and advance Pearson’s postsecondary business objectives nationally, while also collaborating with other internal business leaders and teams on government relations initiatives in assigned states. This position will be responsible for legislative and regulatory activities that affect the business and will ensure stakeholders are kept informed and engaged through the development and execution of government relations strategies. The Principal will build and maintain relationships with government leaders, policymakers, regulators, industry stakeholders, and other external parties within the region and target markets. This...

Location : United States (remote work) Ability to Trave l: May require 25-50% travel Job Description: The Principal of U.S. Government Relations will be a seasoned government relations professional with direct experience in multi-state legislative and regulatory advocacy. The primary responsibility of this role will be to advocate for policies that support and advance Pearson’s postsecondary business objectives nationally, while also collaborating with other internal business leaders and teams on government relations initiatives in assigned states. This position will be responsible for legislative and regulatory activities that affect the business and will ensure stakeholders are kept informed and engaged through the development and execution of government relations strategies. The Principal will build and maintain relationships with government leaders, policymakers, regulators, industry stakeholders, and other external parties within the region and target markets. This...

Location : United States (remote work) Ability to Trave l: May require 25-50% travel Job Description: The Principal of U.S. Government Relations will be a seasoned government relations professional with direct experience in multi-state legislative and regulatory advocacy. The primary responsibility of this role will be to advocate for policies that support and advance Pearson’s postsecondary business objectives nationally, while also collaborating with other internal business leaders and teams on government relations initiatives in assigned states. This position will be responsible for legislative and regulatory activities that affect the business and will ensure stakeholders are kept informed and engaged through the development and execution of government relations strategies. The Principal will build and maintain relationships with government leaders, policymakers, regulators, industry stakeholders, and other external parties within the region and target markets. This...

Location : United States (remote work) Ability to Trave l: May require 25-50% travel Job Description: The Principal of U.S. Government Relations will be a seasoned government relations professional with direct experience in multi-state legislative and regulatory advocacy. The primary responsibility of this role will be to advocate for policies that support and advance Pearson’s postsecondary business objectives nationally, while also collaborating with other internal business leaders and teams on government relations initiatives in assigned states. This position will be responsible for legislative and regulatory activities that affect the business and will ensure stakeholders are kept informed and engaged through the development and execution of government relations strategies. The Principal will build and maintain relationships with government leaders, policymakers, regulators, industry stakeholders, and other external parties within the region and target markets. This...

Location : United States (remote work) Ability to Trave l: May require 25-50% travel Job Description: The Principal of U.S. Government Relations will be a seasoned government relations professional with direct experience in multi-state legislative and regulatory advocacy. The primary responsibility of this role will be to advocate for policies that support and advance Pearson’s postsecondary business objectives nationally, while also collaborating with other internal business leaders and teams on government relations initiatives in assigned states. This position will be responsible for legislative and regulatory activities that affect the business and will ensure stakeholders are kept informed and engaged through the development and execution of government relations strategies. The Principal will build and maintain relationships with government leaders, policymakers, regulators, industry stakeholders, and other external parties within the region and target markets. This...

Administrative Law Examiner 13-P15 (Limited-Term) Print (https://www.governmentjobs.com/careers/michigan/jobs/newprint/5235334) Apply ? Administrative Law Examiner 13-P15 (Limited-Term) Salary $33.53 - $63.10 Hourly Location Multiple Locations Available - See Posting for Details, MI Job Type Limited Term (position has expiration date) Remote Employment Flexible/Hybrid Job Number 6401-25-MOAHR-032 ALE13P15 Department Licensing and Regulatory Affairs - LARA Opening Date 03/03/2026 Closing Date 3/15/2026 11:59 PM Eastern Bargaining Unit NON-EXCLUSIVE REPRESENTED EMPLOYEE (NERE) Description Benefits Questions Job Description Employees in this position function as an administrative law examiner with responsibility for presiding over complex and non-complex administrative hearings relating to the regulatory authority, rules and procedures of the assigned department or agency. Rendered decisions are based on findings of...

Location : United States (remote work) Ability to Trave l: May require 25-50% travel Job Description: The Principal of U.S. Government Relations will be a seasoned government relations professional with direct experience in multi-state legislative and regulatory advocacy. The primary responsibility of this role will be to advocate for policies that support and advance Pearson’s postsecondary business objectives nationally, while also collaborating with other internal business leaders and teams on government relations initiatives in assigned states. This position will be responsible for legislative and regulatory activities that affect the business and will ensure stakeholders are kept informed and engaged through the development and execution of government relations strategies. The Principal will build and maintain relationships with government leaders, policymakers, regulators, industry stakeholders, and other external parties within the region and target markets. This...

Location : United States (remote work) Ability to Trave l: May require 25-50% travel Job Description: The Principal of U.S. Government Relations will be a seasoned government relations professional with direct experience in multi-state legislative and regulatory advocacy. The primary responsibility of this role will be to advocate for policies that support and advance Pearson’s postsecondary business objectives nationally, while also collaborating with other internal business leaders and teams on government relations initiatives in assigned states. This position will be responsible for legislative and regulatory activities that affect the business and will ensure stakeholders are kept informed and engaged through the development and execution of government relations strategies. The Principal will build and maintain relationships with government leaders, policymakers, regulators, industry stakeholders, and other external parties within the region and target markets. This...