Job Title

About Freyr Life Sciences: Freyr Life Sciences is the largest global Regulatory Solutions & Services provider, supporting large, mid, and small global Life Sciences companies in their entire Regulatory value chain. Our services range from Regulatory Strategy, Intelligence, Dossiers, Submissions, to Post-Approval/Legacy Product Maintenance, Labeling, Artwork Change Management, and other related functions. Our Specialties: Include Regulatory Consulting & Strategy, Regulatory Operations & Affairs, Regulatory Software Solutions, Regulatory Information & Intelligence, Global Regulatory Responsibility Services, Regulatory Publishing & Submission, Regulatory Medical Writing, IDMP, Medical Devices Regulatory Services, Regulatory Artwork & Labeling, CMC, and more. With over 1,370 global clients and a presence in over 22 countries, Freyr leverages its expertise to provide comprehensive regulatory support, including intelligence-driven submissions, product registrations, labeling, artwork, post-approval change management, and regulatory software. Job Title: Regulatory Submission Integration specialist Location: Canada (Remote) Job Type: Permanent/Indefinite Summary: The Regulatory Submission Integration specialist is responsible for the end-to-end transfer, validation, and integration of regulatory submission documents and associated metadata from acquired companies into the Veeva Regulatory Information Management (RIM) platform. This role ensures continuity of lifecycle traceability of submissions and submission content by executing a structured, compliant, and high-quality migration process aligned with internal data governance standards, Health Authority expectations, and enterprise integration frameworks. Responsibilities: Document & Data Transfer Execute end-to-end transfer of historic and active regulatory submission documents into Veeva RIM. Collect, organize, and validate legacy regulatory dossiers, CTD/eCTD sequences, HA correspondence, labeling, and supporting documentation. Map legacy metadata to Veeva RIM taxonomy and controlled vocabularies. Data Quality & Compliance Ensure completeness, accuracy, and integrity of metadata and document relationships. Apply internal SOPs, data quality checks, and regulatory compliance standards. Resolve data discrepancies, missing metadata, and document gaps; ensure traceability and audit-readiness. System Integration & Technical Execution Liaise with integration team (Business, DD&D) to support ingestion and validation activities. Support verification cycles, and exception remediation in Veeva environments. Ensure secure document handling and compliance with records retention policies. Documentation & Reporting Maintain transfer logs, provenance records, quality reports, and sign-offs. Contribute to SOPs, playbooks, and continuous improvement of acquisition integration processes. Required Qualifications Bachelors degree in Life Sciences, Pharmacy, Regulatory Affairs, or relevant field. 5+ years in Regulatory Affairs, Regulatory Operations, or related regulatory systems environment. Hands-on experience with CTD/eCTD structure, submission lifecycle management, and regulatory documentation. Experience with Veeva Vault RIM or comparable regulatory systems. Preferred Experience: Prior involvement in M&A regulatory integration, data migration, or remediation projects. Core Competencies: High attention to detail and commitment to data quality excellence. Analytical mindset with structured problem-solving approach. Ability to interpret regulatory structures and requirements. Clear communication skills and ability to influence cross-functional partners. Demonstrated ability to maintain confidentiality and data integrity. Success Indicators: Timely, accurate integration of acquired regulatory submission content into Veeva RIM. Zero critical audit findings related to submission transfer or traceability. Complete and documented submission lineage from source to target system. Positive feedback from regulatory business partners and successful cross-functional collaboration. Benefits: Competitive salary Flexible remote work options Comprehensive health insurance Opportunities for professional development and growth Paid time off and holidays Supportive and collaborative work environment Join our team at Freyr Life Sciences and make a significant impact in the world of regulatory submissions!