GLADYS RODRIGUEZ
Land O' Lakes,USA
Summary
Resourceful and forward-thinking International Labeling Specialist, specializing in regulatory compliance and documentation management across LATAM markets. Proven ability to enhance operational efficiency and ensure adherence to local and international regulations, resulting in significant improvements in labeling accuracy. Adept at leveraging strong analytical and problem-solving skills to navigate complex regulatory environments, and facilitate effective communication between cross-functional teams. Committed to upholding the highest standards of quality assurance, and fostering positive relations across pharmaceutical departments, with a strong track record of delivering compliant and timely submissions to health authorities.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Sr. Regulatory Affairs Specialist
AxoGen
Tampa, FL
12.2024 - Current
- Prepare, author, edit, compile, and review high-quality, clearly messaged documents founded in science, and compliance with regulatory standards for submission to regulatory agencies and health authorities.
- Lead document comment resolution for content issues and questions arising during the authoring process. Assist with the coordination of the review, approval, QC, and other activities involved in the production of regulatory documents.
- Perform data analysis and comprehensive literature reviews to support the U.S. or international regulatory submissions, including regulatory pathway justifications, expanded indications, etc.
- Maintain knowledge of biologics, pharmaceuticals, devices, and tissue regulations, guidance, and standards.
- Participate in cross-functional projects, including new product development, marketing, and design review activities.
- Supports regulatory review of product labels and promotional materials.
- Collaborates with the development of regulatory procedures.
- Ensured compliance with all applicable labeling regulations.
INTERNATIONAL LABELING SPECIALIST - LATAM
Bristol Myers Squibb
Tampa, FL
11.2022 - 12.2024
- Evaluate and manage external requests for country-specific labeling information from various sources, ensuring compliance with FDA and EU regulations.
- Notify relevant internal teams of significant changes or recent source/reference labeling approvals to maintain up-to-date compliance information.
- Prepare and review regulatory compliance documents for product registration, collaborating with cross-functional teams to ensure accuracy and completeness.
- Draft country-specific labeling documents that meet local regulatory requirements and support the safe use of pharmaceutical products.
- Initiate and approve final printed artwork, ensuring it aligns with approved labeling documents and is compliant with all regulatory standards.
- Maintain translation master copies of labeling documents to ensure accuracy and compliance with country-specific requirements.
- Implement a structured documentation process to track changes, approvals, and communications for internal audits and regulatory inspections.
QC MICROBIOLOGY ANALYST III/ENVIRONMENTAL MONITOR
Bausch & Lomb
Tampa, FL
03.2022 - 09.2022
- Performed routine testing for the release of raw materials, finished products, stability samples, and R&D products to ensure compliance with quality standards.
- Conducted environmental and utility monitoring in aseptic areas and cleanrooms using aseptic techniques, including air viable and nonviable testing and surface sampling.
- Identified organisms and maintained laboratory culture collections, ensuring proper preservation and documentation of cultures.
- Contributed to the preparation and review of environmental summaries, ensuring accurate reporting and compliance with regulatory requirements.
- Executed testing in support of facility validation activities, ensuring all processes met established standards.
- Recorded and analyzed pertinent data in appropriate forms or computer systems to maintain data reliability and traceability.
- Reviewed routine manufacturing and quality control data for in-process and finished products, providing insights to enhance quality assurance practices.
ANALYST I, QC INCOMING & SAMPLE MANAGEMENT
Bristol Myers Squibb
Phoenix, AZ
02.2020 - 02.2022
- Conducted sampling and inspection of raw materials, packaging, and finished products using Labware LIMS and Oracle EBS, ensuring compliance with cGMP and FDA regulations.
- Reviewed and revised documents, including material specifications and batch records, to ensure appropriate justification of changes and adherence to regulatory requirements.
- Performed peer reviews of testing data and reported identified issues, assisting in troubleshooting and maintaining data integrity.
- Collaborated with management to implement necessary changes and participated in safety audits for laboratory and inspection areas to ensure compliance with regulatory standards.
- Contributed to continuous improvement projects and CAPA investigations, providing preventive and corrective actions to enhance quality assurance practices.
MICROBIOLOGY LABORATORY SUPPORT COORDINATOR
Life Link Foundation
Tampa, FL
07.2019 - 12.2019
- Processed donor tissue and maintained accurate records using the BTM (Biomaterial Tracking & Management) system to ensure compliance with regulatory standards.
- Received and prepared donated tissue for microbiological cultures, ensuring proper handling and documentation in accordance with best practices.
- Conducted environmental monitoring in ISO Class 5 cleanrooms, contributing to the maintenance of a sterile environment for tissue processing.
- Prepared and managed serology, sterility, and bioburden samples for testing, ensuring timely and accurate distribution of laboratory reports.
- Assisted in equipment calibration and monitoring laboratory equipment temperatures, maintaining compliance with quality assurance protocols.
Education
Bachelor's Degree - Biotechnology, Chemistry
Inter American University of Puerto Rico
Skills
- Expert Problem Solving
- Documentation Management
- Quality Assurance
- Technical Communication
- Root Cause Analysis
- Cross-functional Collaboration
- Global Regulatory Systems
- Manual Dexterity
- Schematics Interpretation
- Business Reporting
- Operational Enhancement
- Regulatory Affairs Expertise
- Analytical Thinker and Problem Solver
- US and Global Regulatory Trends
- Labeling Documents for Submission
- Strong Interpersonal Skills
Certification
- Master Microsoft Word Beginner to Advanced
- TVT X Essentials
- Lean Six Sigma Green Belt
- Hazard Analysis & Critical Control Point
- Six Sigma Foundations
- Equipment Qualification (IQ, OQ, PQ)
- Bioinformatic Methods I
- OSHA 10-Hour General Industry
- FDA Quality Control Inspector
- Good Manufacturing Practices (cGMP's) Pharmaceutical Industry
Timeline
Sr. Regulatory Affairs Specialist
AxoGen
12.2024 - Current
INTERNATIONAL LABELING SPECIALIST - LATAM
Bristol Myers Squibb
11.2022 - 12.2024
QC MICROBIOLOGY ANALYST III/ENVIRONMENTAL MONITOR
Bausch & Lomb
03.2022 - 09.2022
ANALYST I, QC INCOMING & SAMPLE MANAGEMENT
Bristol Myers Squibb
02.2020 - 02.2022
MICROBIOLOGY LABORATORY SUPPORT COORDINATOR
Life Link Foundation
07.2019 - 12.2019
Bachelor's Degree - Biotechnology, Chemistry
Inter American University of Puerto Rico
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