Submissions Implementation Business Analyst

Freyr Digital — a technology-driven company building smart, AI-powered software solutions for the Life Sciences industry , including pharmaceuticals, biotech, and healthcare .

As part of Freyr Solutions , a global leader with over a decade of regulatory expertise, Freyr Digital is revolutionizing traditional processes through cutting-edge digital innovation . By leveraging AI, automation, and cloud-based platforms , we make compliance and regulatory operations faster, more intelligent, and effortlessly scalable for our 200+ global clients across multiple countries.

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Description:

The Submissions Publishing Software Business Analyst is responsible for supporting the implementation, optimization, and ongoing support of regulatory submissions publishing systems. This role serves as a liaison between Regulatory Affairs, IT, and vendors to translate business and regulatory requirements into system configurations, functional specifications, and validated solutions. The ideal candidate has hands-on experience with submissions publishing tools, strong regulatory knowledge, and experience working in highly regulated (GxP) environments.

Key Responsibilities

1. System & Application Support • Support configuration and administration of submissions publishing systems (e.g., Veeva Vault Submissions, Lorenz docuBridge, EXTEDO eCTDmanager, OpenText Publishing). • Configure submission templates, dossier structures, leaf titles, granularity rules, and publishing profiles. • Support system integrations with DMS, RIM, and other regulatory systems. • Assist with system upgrades, patch testing, and vendor coordination.

2. Business Analysis & Requirements • Partner with Regulatory Affairs, Publishing, and IT stakeholders to gather and analyze business and regulatory requirements. • Translate business needs into Functional Requirements Specifications (FRS), Business Requirements Documents (BRDs), and Functional Design Documents (FDDs). • Ensure alignment with global regulatory requirements (FDA, EMA, PMDA, Health Canada, etc.). • Participate in solution design workshops and recommend best practices for submissions publishing.

3. Submissions & Regulatory Compliance • Support eCTD, NeeS, and non-eCTD publishing processes. • Ensure system functionality supports regulatory standards (ICH, FDA, EMA guidance). • Assist in defining and maintaining submission publishing standards, templates, and SOPs. • Ensure compliance with 21 CFR Part 11, Annex 11, and GxP expectations.

4. Testing & Validation • Develop and execute test scripts for system validation activities (IQ/OQ/PQ or UAT). • Validate publishing configurations, submission outputs, lifecycle management, and audit trails. • Support defect triage, root cause analysis, and resolution with IT and vendors. • Ensure validation documentation meets regulatory and quality standards.

5. Deployment & Change Management • Support deployment and configuration promotion across environments (DEV → QA → PROD). • Ensure changes follow formal change control and validation processes. • Assist with creation and maintenance of SOPs, work instructions, and training materials. • Support user training and adoption during rollout and post-go-live.

6. User Support & Continuous Improvement • Provide day-to-day support for regulatory publishing users. • Participate in governance forums to ensure system alignment with global regulatory strategies. • Monitor system usage, performance, and compliance metrics. • Identify opportunities for process automation and efficiency improvements.

Key Qualifications & Skills

Bachelor’s degree in Life Sciences, Regulatory Affairs, Computer Science, or related field. • 3–7 years of experience as a Business Analyst supporting submissions publishing or regulatory systems. • Hands-on experience with submissions publishing software (Veeva Vault Submissions, docuBridge, EXTEDO, OpenText, or similar). • Strong understanding of eCTD structure, publishing workflows, and global regulatory submission processes. • Experience working in regulated environments (GxP, 21 CFR Part 11, Annex 11). • Strong analytical, documentation, and stakeholder management skills. • Experience working with cross-functional and global teams. • Familiarity with integrations between DMS, RIM, and submissions publishing tools.