Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
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Tanya Bass

Summary

Dynamic Global Regulatory Affairs Specialist II at Thermo Fisher Scientific Inc. with a proven track record in regulatory assessment and process improvement. Expert in data management and cross-functional collaboration, successfully enhancing NPI workflows and mitigating compliance risks. Recognized for leadership, problem-solving abilities, and training initiatives that foster team productivity and data integrity.

Overview

12
12
years of professional experience

Work History

Global Regulatory Affairs Specialist

Thermo Fisher Scientific Inc.
10.2016 - 07.2025
  • Conduct product assessments and approve change orders for New Product Introduction (NPI) and attribute changes to the Bill of Substance (BOS) and Bill of Materials (BOM). This process involves reviews in systems such as Agile (CCOs, ECOs, ECRs, MCOs) and Oracle (NIRs, CCOs, CRPIMs).


  • Worked with internal teams to streamline workflow processes, enhancing the turnaround times for New Product Introduction (NPI) launches.


  • Exhibited problem-solving skills and identified potential bottlenecks. Collaborated with cross-functional teams to develop data risk mitigation strategies, reducing potential non-compliance issues.


  • Team Subject Matter Expert (SME), Trained new team members and supervisors on the team's duties and responsibilities.


  • Led and trained the Global and EU RA teams on huge data cleanup projects to maintain data integrity. Worked with IT to implement mass upload changes.


  • Established strong relationships with global regulatory counterparts, facilitating efficient information exchange and collaboration.


  • Utilized the registration database to ensure FDA regulated SKUs are up to date before approvals are made on NPI and change control workflows.


  • Monitored the document retention renewals for all Global/Regional Regulatory Affairs (RA) team members to ensure they are updated and in compliance. Applies to the Standard Operating Procedures (SOPs), Work Instructions (WINs), Forms, and all other quality-related documentation.


  • Created monthly reports and metrics to provide upper management with visibility into the department's turnaround time and scope of work. Escalation of compliance issues to senior management as necessary.

Product Data Management Specialist

Thermo Fisher Scientific Inc.
12.2014 - 10.2016
  • Managed the SKU change control process for New Product Introduction (NPI) and existing SKUs attribute changes, ensuring the change control process complies with company policies and data standards. This process involved data management in the following systems: Agile PLM (ECOs, ECRs, MCOs), SAP, and E1 systems.


  • Ensuring data accuracy and consistency across multiple systems, including the item master, bill of material, and global organization branches.


  • Track the change order workflows to ensure timely completion of global approvals and address any issues that may be causing delays.


  • Provide support to Regulatory Affairs, Quality, Engineering, Manufacturing, Customer Service, and Product/Project managers.


  • Trained new team members.

Document Control / Labeling Coordinator

Pride Staffing (Salter Laboratories)
08.2013 - 06.2014


  • Maintain Instructions for Use (IFU) documents, product labels, and packaging labels in compliance with regulatory standards as well as internal labeling requirements. System Used - BarTender
  • Work with engineering, marketing, manufacturing, and regulatory to facilitate completion of labeling and artwork assignments.
  • Gathered and organized materials to support operations and audits.
  • Enhanced team productivity through regular communication and progress updates.

Education

Certificate - Digital Marketing

Coursera
California, CA
06-2025

Skills

  • Regulatory assessment expertise
  • Process Improvement using AI Agents
  • Problem-Solving skills
  • Data Management and Cross-Functional Collaboration
  • Excellent communication



Accomplishments

  • Responsible for identifying data errors and executing the department data cleanup process insuring the integrity of all Global Regulatory Affairs data attributes.

  • I enhanced the department's productivity for two tedious Excel assessment processes by 75% using AI agents!

  • Updated the department's SOPs and WINs for both the US and EU to ensure compliance with the new Oracle system being implemented in place of Agile.

  • Completed UDI Management PPI - Process improvements to help identify the correct process and revise the outdated WIN.

  • Completed Process Escape Mapping PPI - Improve NPI & On Market workflow to prevent products shipping to the wrong countries.

Timeline

Global Regulatory Affairs Specialist

Thermo Fisher Scientific Inc.
10.2016 - 07.2025

Product Data Management Specialist

Thermo Fisher Scientific Inc.
12.2014 - 10.2016

Document Control / Labeling Coordinator

Pride Staffing (Salter Laboratories)
08.2013 - 06.2014

Certificate - Digital Marketing

Coursera

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