Job Description:Job Description: Associate III – Business Analysis (Regulatory Affairs – Life Sciences Publishing)Role Summary:The Associate III – Business Analyst (Regulatory Affairs – Publishing) plays a crucial role in supporting regulatory operations within the life sciences industry. This role involves understanding stakeholder needs, gathering and analyzing requirements, and assisting in the creation and maintenance of regulatory submission documentation. The associate is also responsible for publishing regulatory submissions in compliance with global health authority standards and guidelines, under guidance from Senior BAs and Regulatory Leads.Key Responsibilities:Business Analysis & Stakeholder EngagementAssist in defining enterprise goals and objectives with stakeholders and leads.Tailor BA approach and communication style based on audience and engagement type.Apply system analysis techniques to evaluate requirements, system capabilities, workflows, and constraints.Contribute to identifying business problems, dependencies, constraints, and solution options early in the project lifecycle.Ensure requirements traceability throughout the project and participate in change control processes.Regulatory Publishing & SubmissionResponsible for electronic publishing (document- and submission-level) of regulatory dossiers (e.g., IND, NDA, ANDA, BLA, MAA, CTA, 510(k), PMA, CE Marking, EU MDR).Format and compile regulatory documents using publishing tools such as Lorenz DocuBridge, Extedo, Veeva Vault.Perform quality checks and validations to ensure compliance with global agency standards (eCTD, NeeS, ACTD).Manage electronic submission through gateways such as ESG, IRIS, and CTIS.Coordinate timelines and collaborate with Regulatory Affairs, CMC, Clinical, and Quality teams.Documentation, Processes & ToolsDocument project and process artefacts clearly and accurately for internal and external stakeholders.Use appropriate tools/templates for requirement documentation and design alignment.Assist in mentoring and knowledge transfer to junior BAs through training artefact creation and logistics support.Ensure adherence to BA and regulatory processes as defined by project leads.Cross-Functional SupportWork collaboratively across RA, QA, Clinical, Pharmacovigilance, and Manufacturing functions to support timely regulatory submissions.Support audits/inspections by maintaining document integrity and traceability.Track submission history, updates, and stakeholder communication using regulatory systems and tools.Required Skills & Competencies:Core Business Analysis Competencies:Proficient in techniques such as: Process Modelling, Root Cause Analysis, Stakeholder Mapping, Risk Analysis, Use Cases, User Stories, Functional Decomposition, Workshops.Strong understanding of BA knowledge areas: Requirements Lifecycle Management, Strategy Analysis, Solution Evaluation, and Communication & Collaboration.Technical & Tools Proficiency:Experience with document publishing and regulatory systems: Lorenz docuBridge, Veeva Vault, Extedo, ArisGlobal, MasterControl.Strong grasp of eCTD structure and validation tools, metadata standards, and electronic submission formats.Skilled in tools for documentation, prototyping, modelling (e.g., Visio, Lucidchart), and collaboration (MS Teams, SharePoint).Regulatory Knowledge:Understanding of global regulatory requirements (FDA, EMA, Health Canada, MHRA, etc.).Familiarity with ICH guidelines, GxP, eCTD, IDMP, XEVMPD, ISO 13485/9001 standards.Exposure to regulatory document standards across product lifecycle (development to post-market).Interpersonal & Communication Skills:Effective in both verbal and written communication, with the ability to adapt communication styles per stakeholder needs.Ability to collaborate with diverse stakeholders including sponsors, SMEs, vendors, and cross-functional teams.Strong negotiation, conflict resolution, and stakeholder engagement capabilities.Organizational & Analytical Skills:Strong analytical, problem-solving, and time management skills.Demonstrates initiative, accountability, and a continuous learning mindset.Able to assess solution impact, risks, and business value.Expected Outcomes & KPIs:Early identification of business constraints, dependencies, and risks.Clear and traceable documentation of requirements and regulatory artefacts.Effective stakeholder communication and engagement across the lifecycle.On-time, compliant regulatory submissions with minimal quality issues.Positive feedback from stakeholders (Senior BAs, PMs, Regulatory Leads).Demonstrated use of tools, frameworks, and BA methodologies.Participation in training and upskilling programs, including certifications.Qualifications & Experience:Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related discipline.4–6 years of experience in Regulatory Publishing and Business Analysis in the Life Sciences domain.Proficient in regulatory publishing tools and regulatory systems.Experience supporting submissions to global health authorities (FDA, EMA, etc.).Familiarity with CSV/Validation processes is a plus.Certifications in Business Analysis (e.g., ECBA, CCBA) or Regulatory Affairs (RAC) preferred.Work Location & Model:Location: [Specify if Remote, Hybrid, or Onsite]Working Model: Cross-functional collaboration across global regulatory and IT teams.Skills:Regulatory Affairs, Publishing,Lorenz DocuBridge, Veeva Vault, Extedo,Quality Management SystemAbout Company:UST is a global digital transformation solutions provider. For more than 20 years, UST has worked side by side with the world’s best companies to make a real impact through transformation. Powered by technology, inspired by people and led by purpose, UST partners with their clients from design to operation. With deep domain expertise and a future-proof philosophy, UST embeds innovation and agility into their clients’ organizations. With over 30,000 employees in 30 countries, UST builds for boundless impact—touching billions of lives in the process.
