NJ Employer Junior Publisher (Regulatory Affairs) in Bridgewater, New Jersey

Skills, Knowledge & Abilities Required:Global Submission/ Publishing of all submissions from a Global perspective and dispatches to worldwide Health Authorities (FDA, EMA, LATAM, ROW). Accountable for all Publishing, verification, dispatch.Working in close collaboration with the Franchise Head of Global Submission Publishing and Global Submission manager, assigned to respective franchise/activity with clear accountability for publishing process.Supporting implementation of Technical Format requirements and collaborates with DRA Operations Submission Standards and Strategy team members to develop company business guidance on publishing deliverables.Responsible for managing all aspects related to the preparation, tracking, compilation, publishing and technical quality control of all assigned maintenance regulatory submissions for assigned franchise. Ensure adherence to internal standards and processes, as well as Health Authoritys requirements.Reporting and updating Franchise Head for Submission Publishing on submission progress. Providing monthly report to immediates and line management within DRA Ops. Identifying issues and solutions relating to timing, quality and resources.Experience:1-3 years of experience in the pharmaceutical industry, with relevant experience in electronic submission publishing, dossier management and dispatch of global drug dossiers (US, EU, Asia, Latin America, etc).Expert in HA submission publishing requirements globally.Knowledge, of Regulatory processes and related tools (document management, publishing, etc.Excellent verbal and written communication skills.Demonstrated ability to be innovative and a creative thinker.Qualifications:Diploma/ Bachelor degree in Pharmacy, Life-ScienceVEVRAA Federal ContractorRequest Priority Protected Veteran ReferralsEOE -Veteran /Disabled/Minority/AA/F/M/SO