Submissions Implementation Business Analyst

Freyr Digital a technology-driven companybuilding 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.

Website Link: https://www.freyrdigital.com/

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. 37 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.