Regulatory Information Management (RIM) Specialist

Inclusion without Exception

Tata Consultancy Services (TCS) is an equal opportunity employer, and embraces diversity in race, nationality, ethnicity, gender, age, physical ability, neurodiversity, and sexual orientation, to create a workforce that reflects the societies we operate in. Our continued commitment to Culture and Diversity is reflected in our people stories across our workforce and implemented through equitable workplace policies and processes.

TCS has been serving the Canadian marketplace for more than 35 years and today is the technology partner of choice for many of the country's leading organizations. As one of the largest IT services providers in Canada and globally, TCS is aiming to become the world's largest AI-led technology services company and is enabling its clients to transform themselves across the full AI stack, from infrastructure to intelligence.

Rooted in the heritage and values of the Tata Group, TCS is focused on creating long-term value for its clients, investors, employees, and the communities it serves. With a highly skilled workforce supporting customers from coast to coast, TCS has consistently been recognized as a Top Employer by the Top Employers Institute, including a recent top ranking at the country level.

TCS also sponsors 14 of the world's most prestigious marathons and endurance events, including the TCS Toronto Waterfront Marathon, reflecting its commitment to health, sustainability, and community empowerment.

Job Description :-

Responsible for managing and maintaining regulatory information within Regulatory Information Management (RIM) system , ensuring accurate, complete, and compliant regulatory data throughout the product lifecycle. The role supports regulatory operations by processing Data Entry Requests (DERs), maintaining Registration Objects (ROs) and Submission Objects (SOs), and facilitating regulatory submissions, registrations, and health authority interactions.

Key Responsibilities

• Process and execute Data Entry Requests (DERs) in accordance with established SOPs and regulatory guidelines.
• Create, update, and maintain Registration Objects (ROs), including registrations, licenses, approvals, renewals, variations, transfers, and withdrawals.
• Create and maintain Submission Objects (SOs), ensuring accurate submission metadata, milestones, and health authority correspondence records.
• Perform regulatory data entry and updates within Regulatory Information Management (RIM) system while ensuring data quality, integrity, and compliance.
• Review and validate regulatory data for accuracy, completeness, and consistency before system updates.
• Track and manage submission and registration lifecycle activities across global markets.
• Support regulatory submission planning, tracking, and post-submission maintenance activities.
• Reconcile and resolve data discrepancies through collaboration with Regulatory Affairs, Regulatory Operations, Publishing, and other cross-functional teams.
• Conduct periodic data quality reviews and audits to ensure compliance with data governance standards.
• Generate regulatory reports, dashboards, and status updates for stakeholders and management.
• Maintain regulatory records and documentation to support audit and inspection readiness.
• Adhere to global regulatory requirements, internal policies, and system governance procedures.
• Participate in process improvement initiatives, system enhancements, testing, validation, and user acceptance activities related to Veeva RIM.
• Managed and maintained xEVMPD data updates and submissions, ensuring compliance with EMA requirements and accurate medicinal product data reporting.
• Supported IDMP data management activities, including data collection, validation, and maintenance of product, substance, organization, and referential data in accordance with ISO IDMP standards.

Key Skills & Expertise

• Regulatory Information Management (RIM) systems
• Regulatory Information Management
• Data Entry Request (DER) Processing
• Registration Object (RO) Management
• Submission Object (SO) Management
• Regulatory Operations
• Registration Lifecycle Management
• Regulatory Data Governance
• Data Quality & Compliance
• Reporting & Analytics
• SOP Compliance
• Stakeholder Management
• Audit & Inspection Support

Soft Skills: Team Collaboration | Effective Communication | Attention to Detail | Problem-Solving

Tata Consultancy Services Canada Inc. is committed to meeting the accessibility needs of all individuals in accordance with the Accessibility for Ontarians with Disabilities Act (AODA) and the Ontario Human Rights Code (OHRC). Should you require accommodation during the recruitment and selection process, please inform Human Resources.

Thank you for your interest in TCS. Candidates that meet the qualifications for this position will be contacted within a 2-week period. We invite you to continue to apply for other opportunities that match your profile.