Regulatory Compliance Specialist
1 week ago
Responsibilities
The Senior Quality Specialist will be responsible for:
- Providing quality oversight and support to site Cell and Gene Therapy operations
- Leading QA efforts to establish new programs supporting Drug Product facility start-up
- Reviewing batch data, including batch records, deviations, in-process data, EM data, and QC release testing
- Approving COAs and product releases
- Providing production floor support and guidance for GMP product quality and compliance
- Resolving product quality investigations and quality issues
- Developing and delivering technical training programs
- Supporting drafting and revising Quality Agreements between CMOs/Suppliers and site
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Regulatory Compliance Specialist
4 weeks ago
Étreux, Hauts-de-France, United States Fiducient Advisors Full timeAbout the RoleFiducient Advisors, a leading investment consulting firm, is seeking an experienced Regulatory Compliance Specialist to join its team.The successful candidate will be responsible for ensuring the firm's compliance with applicable regulatory requirements, collaborating with the Compliance Manager on initiatives that drive new efficiencies, and...
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Regulatory Compliance Specialist
4 weeks ago
Étreux, Hauts-de-France, United States TechnoGen Full timeAbout the RoleWe are seeking a highly skilled Regulatory Compliance Specialist to join our team in Boston, MA.The ideal candidate will have a strong background in regulatory compliance and a passion for ensuring that our business activities align with applicable laws and regulations.
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Regulatory Compliance Specialist
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Étreux, Hauts-de-France, United States Digital Prospectors Full timeOverview:Digital Prospectors, a leading staffing company, seeks an experienced Regulatory Compliance Specialist to support critical GMP and GDP quality activities. This role will ensure the organization is consistently prepared for inspections and audits.Salary: $90,000 - $120,000 per year (dependent on experience)Job Description:We are looking for a highly...
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Senior Regulatory Compliance Specialist
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Étreux, Hauts-de-France, United States Wellington Management Company, LLP Full timeAbout UsWellington Management Company, LLP offers comprehensive investment management capabilities that span nearly all segments of the global capital markets. Our investment solutions, tailored to the unique return and risk objectives of institutional clients in more than 60 countries, draw on a robust body of proprietary research and a collaborative...
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Étreux, Hauts-de-France, United States MFS Investment Management Full timeAbout the RoleMFS Investment Management is seeking a skilled Senior Communications Specialist to join our Global Distribution Communication Oversight Team (GDCOT). This role will be responsible for monitoring and reviewing electronic communications of assigned employees to ensure compliance with FINRA, SEC, and internal guidelines. As a Registered Principal,...
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Compliance and Regulatory Officer
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Étreux, Hauts-de-France, United States Boston Medical Center Full timeJob Description:Boston Medical Center is committed to delivering exceptional patient care and advancing medical innovation. We are seeking a Compliance and Regulatory Officer to join our team, who will play a critical role in ensuring compliance with federal and state laws and regulations.The estimated salary for this role is $110,000 - $160,000 per year,...
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Regulatory Compliance Coordinator
7 days ago
Étreux, Hauts-de-France, United States Infojini Full timeJob DescriptionAs a Regulatory Compliance Coordinator at Infojini, you will play a vital role in maintaining the integrity of our regulatory compliance activities. Your primary responsibilities will include preparing reports, proofreading correspondence, and responding to inquiries related to regulatory inspection and investigation activities.You will work...
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Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full timeJob OverviewThe role of Senior Regulatory Affairs Expert, Labeling Compliance Specialist at Takeda Pharmaceutical is a pivotal position that ensures the company's products meet regulatory requirements and maintain compliance with global labeling standards.This position plays a crucial role in ensuring Takeda gains regulatory approval for new products and...
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Director of Regulatory Compliance
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Senior Regulatory Compliance Officer
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Étreux, Hauts-de-France, United States Disability Solutions Full timeAbout the RoleThe Senior QA Specialist, Document Control plays a vital role in our new product team at Disability Solutions, focusing on improving blood-based cancer diagnostic capabilities. This position requires a strong background in quality assurance and regulatory compliance.Key ResponsibilitiesLead programs, mentor peers, and develop...
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Global Regulatory Compliance Lead
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Étreux, Hauts-de-France, United States State Street Corporation Full timeJob OverviewWe are seeking a seasoned professional to lead our regulatory interactions program, fostering a positive regulatory culture and promoting proactive engagement with regulatory agencies. This senior leadership role contributes to the success of State Street's Corporate Compliance Global Regulatory Liaison Office (GRLO).About the RoleThis highly...
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Regulatory Compliance Expert
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Étreux, Hauts-de-France, United States Verista Full timeOur team at Verista is committed to delivering exceptional results and driving business success through our passion for quality and innovation. As a Senior Quality Specialist, you will have the opportunity to contribute to our mission by leading QA efforts, reviewing batch data, and determining product disposition acceptability. With your expertise in GMP...
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Étreux, Hauts-de-France, United States National Black MBA Association Full timeThis role will be responsible for ensuring adherence to global compliance standards and FDA regulations in the creation, review, and approval of advertising and promotional materials.As a Director, Advertising and Promotion Compliance, you will serve as the Regulatory Affairs representative for assigned products and therapeutic areas. You will engage...
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Étreux, Hauts-de-France, United States MFS Investment Management Full timeAbout MFS Investment ManagementMFS Investment Management is a leading investment manager dedicated to building a culture that supports employees in doing what they do best. Our team works together to achieve better outcomes, prioritizing the strongest ideas over individual interests. We value people above all else, demonstrating care and compassion for our...
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Associate Director of Regulatory Compliance
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Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full timeAbout the RoleThe Associate Director, Global Labeling Lead will play a critical role in shaping our global labeling strategy and ensuring compliance with regulatory requirements. This individual will oversee the development and implementation of labeling content and strategy for multiple assigned products, working closely with cross-functional teams to drive...
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Regulatory Compliance Expert
4 weeks ago
Étreux, Hauts-de-France, United States Cognizant Full timeCompliance Lead Position OverviewCognizant Technology Solutions seeks a seasoned QEA Compliance Lead with extensive expertise in Quality Engineering and Assurance to oversee the assessment of GxP systems, conduct risk assessments, and ensure compliance with regulatory standards.About CognizantWe're a global leader in digital transformation, serving clients...
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Étreux, Hauts-de-France, United States Edgewise Therapeutics Full timeAbout Edgewise Therapeutics:Edgewise Therapeutics is a leading biopharmaceutical company focused on developing innovative medicines for serious muscle diseases. Our mission is to improve the lives of patients by harnessing our expertise in muscle biology and biophysics.We are committed to building a strong leadership team with a track record in the...
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Étreux, Hauts-de-France, United States Takeda Pharmaceutical Full timeJob Overview:The Regulatory Compliance Lead for Global Labeling Initiatives will play a pivotal role in ensuring Takeda Pharmaceutical's products gain regulatory approval across the globe while maintaining currency of product licenses and permits. This senior position contributes to the company's mission by guaranteeing compliance with legislation and...
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Regulatory Compliance Director
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Étreux, Hauts-de-France, United States Fidelity TalentSource LLC Full timeAbout the Role">This role is a key part of Fidelity Digital Asset Services, LLC's Compliance team. As a trusted business partner, you will promote a culture of ethical conduct and commitment to compliance, regulatory, and legal obligations.You will support regulatory oversight of FDAS, collaborating closely with various teams within FDAS and across the...
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Cybersecurity Compliance Specialist
4 weeks ago
Étreux, Hauts-de-France, United States Sterling Partners Full timeJob OverviewWe are seeking a highly skilled Cybersecurity Compliance Specialist to join our team at Sterling Partners.About the RoleThe Cybersecurity Compliance Specialist will be responsible for ensuring that our services, applications, and systems comply with current cybersecurity standards and regulatory requirements. This role will develop and implement...