Regulatory Affairs Intelligence Analyst

Regulatory Intelligence SpecialistLocation: South San Francisco, CAWork Model: Onsite (No Exceptions)Employment Type: ContractContract Duration: 12 months (Potential to extend)Pay Rate: $30.00 – $34.77/hour on w2 only (C2C/1099 - not available)About the OpportunityWe are seeking a highly organized and detail-oriented Regulatory Intelligence Specialist to support a leading biotechnology organization in South San Francisco. This role will focus on monitoring global regulatory developments, conducting regulatory research, maintaining intelligence databases, and delivering actionable insights to cross-functional stakeholders.The ideal candidate will have experience in Regulatory Affairs, Regulatory Operations, or Regulatory Intelligence within the pharmaceutical, biotechnology, or life sciences industry.Key ResponsibilitiesMonitor and track global regulatory developments, including FDA, EMA, and other health authority guidance updates, policy changes, and compliance requirementsConduct structured regulatory research using health authority websites, industry publications, databases, and internal systemsAnalyze, filter, and prioritize regulatory intelligence relevant to ongoing development programs and business objectivesPrepare concise regulatory intelligence summaries, reports, and briefings for internal stakeholdersTrack competitor regulatory activities, including product approvals, submissions, label changes, and pipeline updatesMaintain and update regulatory intelligence databases, trackers, dashboards, and knowledge management systems such as Veeva VaultPerform data entry, validation, and quality checks to ensure integrity and accuracy of regulatory recordsOrganize and standardize regulatory information to improve accessibility, reporting, and analysisSupport the creation and maintenance of dashboards, reports, and operational tracking tools for leadership visibilityRespond to ad hoc regulatory intelligence requests from Regulatory Affairs, Clinical, and Program teamsSupport audit readiness by ensuring documentation is complete, accurate, and compliant with internal processesIdentify process improvement opportunities and recommend enhancements to workflows, systems, and reporting toolsUtilize AI and digital tools where applicable to improve efficiency in data collection, summarization, and reportingManage multiple priorities and deadlines in a fast-paced, highly regulated environmentRequired QualificationsBachelor’s degree in Life Sciences, Regulatory Affairs, Pharmacy, Biotechnology, or related field2+ years of experience in Regulatory Affairs, Regulatory Intelligence, Regulatory Operations, or related functionsExperience within pharmaceutical, biotechnology, medical device, or life sciences industriesFamiliarity with global health authorities including FDA, EMA, and ICH guidelinesStrong research, analytical, and organizational skillsExperience working with regulatory databases, document management systems, or platforms such as Veeva VaultProficiency with Microsoft Office tools, especially Excel and PowerPointExcellent written and verbal communication skillsAbility to work onsite in South San Francisco, CAPreferred QualificationsExperience supporting global regulatory intelligence activitiesFamiliarity with competitor intelligence tracking and regulatory reportingExposure to dashboarding, reporting tools, or data visualization platformsExperience leveraging AI or digital automation tools within regulatory workflowsKnowledge of GxP/GMP regulated environmentsWhy Join?This is an exciting opportunity to support a world-class biotechnology organization and gain exposure to global regulatory strategy, intelligence operations, and cross-functional collaboration within a highly innovative environment.