Regulatory Affairs Manager
Designation
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 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 worldwide
Escalation 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 projects
Review and resolution of QMS corrective actions and CAPA Plans
Requirements
Proven experience developing and managing Quality Processes, implementation of QMS
Ability to conduct internal audits or manage external audits as an auditee
Knowledge of the software development and testing process, especially for Agile development
Ability to understand high-level technical concepts to provide review and commentary on project documents
Excellent written communication skills in English
Familiarity 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
Professional 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.
Regulatory Affairs Project Manager
To support their goals, they need a Regulatory Affairs Project Manager to join the team and ensure their new drug goes all the way from inception through to FDA approval and market. Lead and oversee the preparation and submission of all regulatory documents, including the IND application, as well as...
Manager/Senior Manager, Regulatory Affairs
Manager/ Senior Manager, Regulatory Affairs. As Manager, Regulatory Affairs you are part of a specialized consulting team providing strategic regulatory and permitting advice and services to private, Indigenous, and public-sector clients engaged in resource, infrastructure, and community development...
Senior Regulatory Affairs Manager - Contract
Act as the local operational lead for the Regulatory team and focal point for cross-functional stakeholders, supporting the acting Head of Regulatory Affairs for Canada (based in Switzerland), to ensure adequate support and continuity of regulatory activities for the Prescription, Aesthetic and Cons...
Manager, Research Regulatory Affairs
Under the general direction of the Director, Operations, Research Safety & Compliance, Environmental Health and Safety, and with scientific advice from the Chairs of the University safety committees (IBBC, ILSC, LSC and UTRPA), the Manager, Research Regulatory Affairs manages the University's regula...
Manager, Regulatory Affairs
Provide regulatory oversight on all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Communicate regulatory changes, progress of proceedings across Canada and provide regulatory expertise to DE Canada Home, DE Canada B...
Manager, Research Regulatory Affairs
Under the general direction of the Director, Operations, Research Safety & Compliance, Environmental Health and Safety, and with scientific advice from the Chairs of the University safety committees (IBBC, ILSC, LSC and UTRPA), the Manager, Research Regulatory Affairs manages the University's re...
Manager, Regulatory Affairs
Reporting to the Director, Regulatory Affairs as part of the NRG Regulatory Affairs team. Provide regulatory oversight on all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Communicate regulatory changes, progress of...
Senior Manager, Regulatory Affairs Information Management Systems - Now Hiring!
Responsibilities include organizing regulatory operations aspects of projects/products, including - managing the planning, tracking of applications and other structured data to regulatory agencies, - identifying and ensuring adherence to relevant submission standards, - initiating/maintaining relati...
Sr Manager, Regulatory Affairs
Reporting to the Chief Finance Officer & VP Corporate Services, the Senior Manager Regulatory Affairs, is responsible for responding to all regulatory matters for the Company which includes monitoring of telecommunication regulatory activities, responding to regulatory requirements, and communicatio...
Manager, Regulatory Affairs (Temporary Full Time)
Certification in Regulatory Affairs (RAC) and /or Prior consulting experience an asset. Regulatory Affairs or related relevant experience within the health care products industry, or consulting. Co-ordinate and compile regulatory submissions, responses to agency questions and other correspondence in...