Regulatory Affairs Manager
2 weeks ago
Designation Manager, QRCExperience 5+ yearsJob Responsibility Responsible for ensuring SI products and services are compliant to relevant government and industry regulations including but not limited to: 21CRF11, ISO 27001, ISO 9001, ICH GCP, GAMP5, and Guidance for Industry - Computerized Systems used in Clinical Trials. Assist in leading QRC for Quality Management System (QMS) development and improvement, training and process.Assist in leading internal audits to assess compliance to SI QMS. Represent or assist SI in external audits. Provide project document and test review and approval in compliance with established SI software development lifecycle (SDLC) requirements. Roles & Responsibilities Customer Audit Program: assist in scheduling, hosting, and follow up on all customer audits. Provide responses to customer audit reports and follow up (to close out) on resulting corrective actions.Carry out vendor audits, including on-site audit, providing vendors with formal reports which enumerate findings and observations requiring corrective action, and following up with vendors to assure that corrective actions are taken.Support implementation and validation of internal computer systems (QMS, Training, CAPA) to support quality framework.Support clients undergoing regulatory inspections in which company systems have been used.To stay abreast of industry and federal regulations, and provide guidance and expertise to the global organization in the areas of regulatory compliance and quality. Provide input and guidance from a regulatory and quality perspective to functional areas of the corporation to facilitate decision making related to product development/release, delivery of services and customer relations. To maintain, modify and grow the corporate Quality Management System to comply with industry and federal regulations and corporate strategic goals.To manage revision and approval of department Quality System Policy and SOPs.Provide assistance and expertise toward the improvement of training programs across the organization and all functions.To perform internal quality audits of the organization, including quality system inspection and reporting for all product releases and release of projects.To maintain a cross-reference listing between the relevant sections and components of regulatory documents and the manner by which the Products and Services comply with those regulations cited.Additional responsibilities would include, but not be limited to: Review products, systems, deliverables and documentation for:Conformance to regulatory requirements and applicable guidance worldwideEscalation of issues pertaining to non compliance, privacy, data integrity, and security for investigation and documentation of corrective and preventive action. Develop, maintain, and report: Incidence of defects, audit findings and rates of occurrence and closure of outstanding issues.Review process documentation for compliance to SOP’s and applicable regulations such as:Guidance and management of process and product improvement projectsReview and resolution of QMS corrective actions and CAPA PlansRequirementsProven experience developing and managing Quality Processes, implementation of QMSAbility to conduct internal audits or manage external audits as an auditeeKnowledge of the software development and testing process, especially for Agile developmentAbility to understand high-level technical concepts to provide review and commentary on project documentsExcellent written communication skills in EnglishFamiliarity with regulated software requirements and standards Education Qualification Bachelor’s degree, preferably in a scientific discipline, Computer Science or any other related discipline with a MS degree being a plus. Access Level LowProfessional Qualification/certification Exposure on ICH-GCP guidelines and Code of Federal Regulations (CFR) Title 21, Part 11 that covers the management of electronic records, electronic signatures and computer system validation.
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Director, Regulatory Affairs
2 weeks ago
Canada Canadian Imperial Bank of Commerce Full timeDirector, Global Regulatory Affairs page is loaded Director, Global Regulatory Affairs Apply locations Toronto, ON time type Full time posted on Posted 2 Days Ago job requisition id 2411137 We’re building a relationship-oriented bank for the modern world. Global Regulatory Affairs (GRA) is CIBC’s central point-of-contact with global prudential...
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Regulatory Affairs Officer
1 month ago
Canada Groupe ProductLife Full timeIn the context of additional activities for one of our main clients, we are looking for a Regulatory Affairs Officer working from Mexico or Canada to manage post-MAA activities (Life Cycle Management) for the Canadian market. Responsibilities Management of post approval activities (Life Cycle Management) for the Canadian market Initiate change...
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Regulatory Affairs Specialist
1 month ago
Canada Groupe ProductLife Full timeIn the context of additional activities for one of our main clients, we are looking for a Regulatory Affairs Officer working from Mexico or Canada to manage post-MAA activities (Life Cycle Management) for the Canadian market. Initiate change controls, including regulatory assessment of the change in accordance with Health Canada guidances. Coordinate and...
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Canada Impact HR Full timeThe OpportunityImpact HR is proud to represent an excellent opportunity within the Western Canadian resources sector. Our client, an expanding energy company based in Calgary, AB, is dedicated to evaluating and developing its properties with an innovative and responsible multi-decade approach. As a part of the team, you'll have the opportunity to contribute...
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Canada Impact HR Full timeThe OpportunityImpact HR is proud to represent an excellent opportunity within the Western Canadian resources sector. Our client, an expanding energy company based in Calgary, AB, is dedicated to evaluating and developing its properties with an innovative and responsible multi-decade approach. As a part of the team, you'll have the opportunity to contribute...
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Canada Impact HR Full timeThe OpportunityImpact HR is proud to represent an excellent opportunity within the Western Canadian resources sector. Our client, an expanding energy company based in Calgary, AB, is dedicated to evaluating and developing its properties with an innovative and responsible multi-decade approach. As a part of the team, you'll have the opportunity to contribute...
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Director, Global Regulatory Affairs
2 weeks ago
Canada Canadian Imperial Bank of Commerce Full timeDirector, Global Regulatory Affairs page is loaded Director, Global Regulatory Affairs Apply locations Toronto, ON time type Full time posted on Posted 2 Days Ago job requisition id 2411137 We’re building a relationship-oriented bank for the modern world. We need talented, passionate professionals who are dedicated to doing what’s right for our...
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canada Impact HR Full timeThe Opportunity Impact HR is proud to represent an excellent opportunity within the Western Canadian resources sector. Our client, an expanding energy company based in Calgary, AB, is dedicated to evaluating and developing its properties with an innovative and responsible multi-decade approach. As a part of the team, you'll have the opportunity to...
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Canada Impact HR Full timeThe Opportunity Impact HR is proud to represent an excellent opportunity within the Western Canadian resources sector. Our client, an expanding energy company based in Calgary, AB, is dedicated to evaluating and developing its properties with an innovative and responsible multi-decade approach. As a part of the team, you'll have the opportunity to...
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Regulatory Affairs Manager
1 month ago
Canada Sycamore Informatics, Inc. Full timeDesignation Manager, QRCExperience 5+ yearsJob Responsibility Responsible for ensuring SI products and services are compliant to relevant government and industry regulations including but not limited to: 21CRF11, ISO 27001, ISO 9001, ICH GCP, GAMP5, and Guidance for Industry - Computerized Systems used in Clinical Trials. Assist in leading QRC for Quality...
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Regulatory Affairs Manager
1 month ago
Canada Sycamore Informatics, Inc. Full timeDesignation Manager, QRC Experience 5+ years Job Responsibility Responsible for ensuring SI products and services are compliant to relevant government and industry regulations including but not limited to: 21CRF11, ISO 27001, ISO 9001, ICH GCP, GAMP5, and Guidance for Industry - Computerized Systems used in Clinical Trials. Assist in leading QRC for...
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Regulatory Affairs Manager
1 month ago
Canada Sycamore Informatics, Inc. Full timeDesignation Manager, QRCExperience 5+ yearsJob Responsibility Responsible for ensuring SI products and services are compliant to relevant government and industry regulations including but not limited to: 21CRF11, ISO 27001, ISO 9001, ICH GCP, GAMP5, and Guidance for Industry - Computerized Systems used in Clinical Trials. Assist in leading QRC for Quality...
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Regulatory Affairs Manager
1 month ago
Canada Sycamore Informatics, Inc. Full timeDesignation Manager, QRC Experience 5+ years Job Responsibility Responsible for ensuring SI products and services are compliant to relevant government and industry regulations including but not limited to: 21CRF11, ISO 27001, ISO 9001, ICH GCP, GAMP5, and Guidance for Industry - Computerized Systems used in Clinical Trials. Assist in leading QRC for...
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Regulatory Affairs Manager
3 weeks ago
Canada, CA Sycamore Informatics, Inc. Full timeDesignation Manager, QRCExperience 5+ yearsJob Responsibility Responsible for ensuring SI products and services are compliant to relevant government and industry regulations including but not limited to: 21CRF11, ISO 27001, ISO 9001, ICH GCP, GAMP5, and Guidance for Industry - Computerized Systems used in Clinical Trials. Assist in leading QRC for Quality...
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Graduate - Regulatory Affairs
2 weeks ago
Canada Lipa Pharmaceuticals Limited Full timeQuality Assurance & Control (Science & Technology) Full time Add expected salary to your profile for insights Lipa Pharmaceuticals began in 1995 as a small family business, with a firm belief that our achievements are measured by the growth and success of our customers. We are now Australia’s first choice for complementary medicines manufacturing with...
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Legal Counsel, Regulatory Affairs
2 weeks ago
Canada TMX Group Full timeLegal Counsel, Regulatory Affairs page is loaded Legal Counsel, Regulatory Affairs Apply locations Toronto - 100 Adelaide St W Calgary - 300, 5th Ave Vancouver - 650 West Georgia St time type Full time posted on Posted 2 Days Ago job requisition id R-4125 Venture outside the ordinary - TMX Careers The TMX group of companies includes leading global...
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Canada Impact HR Full timeOur client, an expanding energy company based in Calgary, AB, is dedicated to evaluating and developing its properties with an innovative and responsible multi-decade approach. Our client is focused on creating an environment where everyone is empowered to make impactful decisions that support the company’s goals. It’s a company with a long-term view and...
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Manager, Quality Operations
2 days ago
Canada Summit Search Group Full timeAbout Our Client: Our client is a dominant and leading electric utility organization. Reporting to the Vice-President, Engineering and Operations, the Manager of Operations provides leadership and assumes overall responsibility for the construction and maintenance of overhead and underground distribution system. This position will oversee the...
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Senior Regulatory Affair Specialist
1 month ago
Canada LemFi Full timeLemFi ( ) is building the neo-bank for the African diaspora in North America & Europe & the UK. We provide our users with a multi-currency account that allows them to hold, send, and receive money from Africa in any currency for their business and personal banking needs. You are a candidate who would thrive in a fintech startup environment like...
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Senior Medical Affairs Manager, Biosimilars
1 month ago
Canada Biogen, Inc. Full timeSenior Medical Affairs Manager, Biosimilars Full-time Region: EU+/Canada About This Role The Biosimilars Business Unit (BBU) is dedicated to the provision of biosimilar medications to patients across an extended range of therapeutic areas including dermatology, gastroenterology, rheumatology and ophthalmology (retinal vascular diseases). Realizing the...
