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Job Title Life Sciences Regulatory Affairs RA Associate - Publishing Job Summary We are looking for a skilled and experienced Regulatory Affairs Associate - Publishing to join our Life Sciences Practice The ideal candidate will support global regulatory submission activities by managing electronic publishing document-level and submission-level collaborating with cross-functional teams and ensuring compliance with international regulatory standards throughout the product lifecycle This role requires a blend of business analysis acumen strong communication skills stakeholder engagement and hands-on expertise with regulatory publishing tools and systems Key Responsibilities Regulatory Publishing Documentation Compile format and publish regulatory submissions including but not limited to INDs NDAs BLAs MAAs ANDAs CTAs DMFs 510 k PMAs CE Marking documents and other regional submissions FDA EMA Health Canada MHRA RoW Ensure adherence to eCTD NeeS and regional submission formats using tools such as Lorenz DocuBridge Veeva Vault and Extedo Conduct document-level and submission-level publishing with full version control metadata tagging hyperlinking and bookmarking Perform detailed quality control QC checks and validation of regulatory submissions to meet global standards Ensure compliance with regulatory submission gateways e g ESG IRIS CTIS manage submission archives and track dispatches Stakeholder Engagement Collaboration Liaise with internal and external stakeholders RA Clinical CMC QA PV Manufacturing etc to gather and finalize documents for submission Collaborate with cross-functional teams to define submission requirements resolve issues and align on publishing timelines Lead stakeholder communications by adapting technical content for clear understanding and informed decision-making Business Analysis Process Optimization Analyze and define regulatory business needs proactively identify gaps risks and opportunities for submission process improvement Leverage tools and templates for requirements gathering change control document management and impact assessments Participate in continuous process improvement recommending enhancements in publishing workflows and systems Develop and maintain reusable artifacts templates and documentation standards across projects Compliance Standards Maintain up-to-date knowledge of regulatory guidelines ICH FDA EMA EU MDR etc Support audits and inspections by ensuring documentation readiness and submission traceability Ensure submissions meet organizational and global health authority standards Expected Outcomes Measures of Success Timely and accurate regulatory submissions with zero non-compliance issues Effective communication and collaboration with stakeholders across functions and geographies Business value contribution through process innovation documentation standardization and reuse of tools artifacts Positive customer and stakeholder feedback on submission quality and engagement Continuous upskilling in relevant tools regulations and business analysis methodologies Required Qualifications Experience Graduate Postgraduate in Pharmacy Life Sciences or related field 4-6 years of experience in Regulatory Publishing document and submission level Hands-on expertise in publishing tools like Lorenz DocuBridge Veeva Vault Extedo and eCTD validation tools Strong understanding of global submission standards eCTD NeeS electronic gateways ESG IRIS etc and version control practices Familiarity with RIM DMS and regulatory tracking systems Knowledge of regulatory affairs across the product lifecycle pre and post-marketing submissions license maintenance variations renewals Desirable Skills Competencies Business Analysis Competencies Proven ability to elicit document and manage regulatory requirements Experience in conducting stakeholder interviews document analysis impact assessments and gap analyses Strong analytical and problem-solving capabilities to evaluate solution options and provide recommendations Familiarity with BA techniques process modeling root cause analysis stakeholder mapping etc Soft Skills Excellent communication written and verbal interpersonal and collaboration skills Strong time management and organizational skills High degree of accountability adaptability and attention to detail Tools Technologies Experience using BA tools and platforms JIRA Confluence MS Visio SharePoint Excel advanced etc Proficiency in document control systems submission archiving tools and publishing platforms Additional Responsibilities as required Support junior team members and participate in mentoring activities Assist in identifying new business opportunities and contribute to pre-sales regulatory solutions as requested by leadership Participate in internal knowledge-sharing sessions BA RA CoEs and training activities Location Work Environment Flexible work environment with hybrid remote options based on project client requirements May require occasional travel for stakeholder workshops or audits 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