GLOBAL REGULATORY SPECIALIST RESUME EXAMPLE

Published: Apr 21, 2025 - The Global Regulatory Specialist ensures the preparation and review of regulatory documents with clarity, accuracy, and adherence to established timelines. This role supports effective collaboration with internal teams and external partners to maintain document integrity, meet regulatory requirements, and facilitate clear communication. The specialist also promotes a safe and respectful working environment by upholding safety, security, and stewardship standards across all functions and regions.

Tips for Global Regulatory Specialist Skills and Responsibilities on a Resume

1. Global Regulatory Specialist, BioNova Therapeutics, Durham, NC

Job Summary: 

  • Support the Global Regulatory Portfolio Teams by delivering documentation for discrete sub-projects to ensure the timely delivery of outputs and flexibility of resources
  • Prepare strategy documents, data gathering for submissions, preparation of certifications, and issuing letters of access
  • Support the Global Regulatory Portfolio Teams by scoping and delivering specific Regulatory notifications such as notifications of changes of manufacturing sources, name changes, and address changes
  • Work closely with the Supply Chain to ensure compliance during transition phases
  • Support the Global Regulatory Portfolio Teams by gathering Regulatory information on specific topics (such as Regulatory requirements) and making it available to the Regulatory Department
  • Support the Global Product Chemistry and or Product Safety experts by preparing standardized assessments, data summaries, data sheets, dossiers and other documentations which are accurate, complete, and consistent with company standards
  • Expert user of Global Regulatory Knowledge Management Systems concerning data entry, data searching and publishing reports
  • Identify and analyse new rules and regulations globally
  • Interact with a diverse group of impacted partners from all divisions to ensure that new regulatory requirements are addressed appropriately within the organization
  • Maintain and document in-depth knowledge of Credit Suisse business operations and structures in all relevant jurisdictions
  • Contribute to change projects which aim to enhance the Regulatory Change Management process, as well as improve the overall provision of the function’s service
  • Cooperate with members of the global Regulatory Foresight and Intelligence department to increase collaboration and develop the Operating Model for Regulatory Change Management


Skills on Resume: 

  • Regulatory Documentation (Hard Skills)  
  • Data Analysis (Hard Skills)  
  • Regulatory Compliance (Hard Skills)  
  • Cross-Functional Collaboration (Soft Skills)  
  • System Proficiency (Hard Skills)  
  • Change Management (Soft Skills)  
  • Stakeholder Engagement (Soft Skills)  
  • Information Gathering (Hard Skills)

2. Global Regulatory Specialist, GreenMed Solutions, Rochester, NY

Job Summary: 

  • Work with key partners in the review and release of products into the markets
  • Manage the collection of regulatory data from operating units
  • Develop key partnerships with stakeholders across functional groups, operating units, and regions to align on harmonized processes
  • Analyze current state process structure, including alignment with any IT systems, to aid in the development of future state structure
  • Analyze IT system changes for registration impacts
  • Initiates special projects with minimal direction from the manager, including collecting and analyzing data and presenting results
  • Respond to various data requests and ad hoc reporting needs of operating units and regions
  • Mentor and direct colleagues in achieving department objectives and in compliance with policies and procedures
  • Maintains templates based on the latest information received
  • Participates in the development and maintenance of work practices
  • Serves as liaison with outside partners and performs special tasks 


Skills on Resume: 

  • Product Release (Hard Skills)  
  • Data Collection (Hard Skills)  
  • Process Alignment (Soft Skills)  
  • System Analysis (Hard Skills)  
  • Project Management (Soft Skills)  
  • Report Generation (Hard Skills)  
  • Team Mentoring (Soft Skills)  
  • Partner Liaison (Soft Skills)

3. Global Regulatory Specialist, NovaCore Biotech, Des Moines, IA

Job Summary: 

  • Make safety a key consideration for all activities by working to support a safe working environment for both oneself and others
  • Comply with all FMC safety and security policies
  • Comply with the principles of Responsible Care and promote Product Stewardship
  • Interact with all coworkers and external partners fairly and respectfully
  • Provide oversight of the process of preparing assigned regulatory documents
  • Prepare, assemble, and review draft documents for clarity, completeness, and accuracy
  • Work with Country, Regional, and Global Regulatory Managers, Supply Chain, Legal, Stewardship, and others to produce documents that are true and correct
  • Monitor the timelines of ongoing documents
  • Develop and maintain a good working relationship with outside partners
  • Ensure documents are properly filed while in draft format and as final documents
  • Ensure the appropriate level of communication with key stakeholders regarding progress and changes to the documents
  • Manage relationships across all divisions, functions and regions


Skills on Resume: 

  • Safety Compliance (Hard Skills)  
  • Policy Adherence (Hard Skills)  
  • Product Stewardship (Soft Skills)  
  • Respectful Communication (Soft Skills)  
  • Document Oversight (Hard Skills)  
  • Quality Review (Hard Skills)  
  • Stakeholder Coordination (Soft Skills)  
  • Relationship Management (Soft Skills)
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