Regulatory Requirements Lead - Global Regulatory Intelligence

Role Summary - We are seeking experienced and meticulous CMC Lifecycle Experts to join our Regulatory Intelligence team. This pivotal role focuses on leveraging CMC regulatory affairs experience to maintain our comprehensive regulatory requirements database (GRR). This involves analyzing regulatory nuances and ensuring the accuracy of content in the database.This position requires good understanding of CMC regulations, particularly in major markets such as the EU or US, and will apply prior hands-on regulatory affairs experience to enhance our regulatory intelligence capabilities, rather than performing direct regulatory submissions.Strategic Database Development & Management:Contribute to the development, population, and ongoing maintenance of the Global Regulatory Requirements (GRR) database.Leverage prior regulatory affairs experience to input, verify, and regularly review data related to variation classifications, procedural requirements, and documentation needs.Interpret and translate complex regulatory guidelines and change conditions into structured, searchable, and user-friendly information for regulatory professionals.Provide guidance and feedback to team members to enhance data accuracy and identify efficient methods for managing deliverables.Achieve assigned data review and finalization targets within defined timelines.Collaborate with cross-functional teams—including IT, Development, and other stakeholders—to optimize database functionality, usability, and overall performance.Collaborate closely with cross functional teams and departments as needed to complete the assigned tasks.**Minimum of 5 years of progressive experience in Regulatory Affairs, with a significant focus on CMC lifecycle management within the pharmaceutical industry.Mandatory demonstrable experience with variation requirements in major markets, including the European Union (EU) or the United States (US).Experience with other key global markets (e.g., Canada, Australia, Japan, ASEAN) is highly desirable.Proficiency in CTD format principles and understanding of global submissionMandatory - Excellent communications skillsExperience in CMC filings, Post approval changes, Life Cycle Management, Change ControlKnowledge in Regulatory Intelligence & guidelines

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