Associate Iii

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 Engagement Assist 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 Submission Responsible 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 Tools Document 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 Support Work 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 System About 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