Summary
Overview
Work History
Education
Skills
Accomplishments
Interests
Timeline
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John Michael Rondello

Davenport,FL

Summary

Dynamic Senior Regulatory Affairs Associate at Pfizer with a proven track record in regulatory submissions and compliance. Expert in FDA regulations and document control, I led successful product launches while fostering teamwork and collaboration. My analytical skills streamlined processes, enhancing efficiency and ensuring high-quality outcomes in a fast-paced environment.

Equipped with strong problem-solving abilities, willingness to learn, and excellent communication skills. Poised to contribute to team success and achieve positive results. Ready to tackle new challenges and advance organizational objectives with dedication and enthusiasm.

Overview

37
37
years of professional experience

Work History

Senior Regulatory Affairs Associate

Pfizer
08.1987 - 08.2007
  • Ensured effective post-market surveillance by overseeing adverse event reporting systems and coordinating recalls when necessary.
  • Provided expert guidance on interpretation of clinical trial data for inclusion in regulatory submissions, showcasing strong analytical skills.
  • Prepared high-quality submissions for FDA approval, leading to successful product launches in a timely manner.
  • Led efforts to harmonize internal SOPs with global standards through regular reviews and updates, fostering consistency across business units worldwide.
  • Optimized the use of electronic submission systems by providing technical support and training to team members, increasing overall efficiency.
  • Managed the preparation and review of regulatory documentation, ensuring compliance with international guidelines and regulations.
  • Streamlined regulatory submission process by implementing a robust tracking system, resulting in improved efficiency and timely approvals.
  • Maintained and archived regulatory paperwork.
  • Prepared and submitted over 100 regulatory file applications and supporting documentation.

Quality Assurance Inspector

Pfizer
04.1982 - 08.1987
  • Performed visual inspections and non-destructive tests where appropriate
  • Communicated with production team members about quality issues.
  • Reported repeated issues to supervisors and other departments, collaborating to identify issue roots and rectify problems.
  • Maintained accurate records of inspection findings, facilitating data-driven decision-making for process improvements.
  • Kept detailed records of quality and imperfect products.
  • Identified where product issues were coming from and rectified issues.
  • Influenced positive change within the organization by driving a culture focused on high-quality products and services.
  • Recommended changes to assembly and production lines based on repeat product issues.

Technical Information Coordinator

Pfizer
04.1975 - 04.1982
  • Enhanced data accuracy for management decision-making through meticulous record-keeping and documentation for over 5000 specifications and standard test procedures..
  • Updated internal databases regularly with current employee information for various reporting purposes.
  • Streamlined information flow by implementing efficient coordination processes and procedures.
  • Contributed to the development of policies and procedures relating to information management practices within the organization.
  • Resolved issues through active listening and open-ended questioning, escalating major problems to manager.

Laboratory Technician

Pfizer
06.1970 - 04.1975
  • Maintained a high level of accuracy in test results by following strict quality control procedures.
  • Operated basic laboratory equipment such as balances, pH meter, colorimeter, spectrophotometer, autoclave and evaporator.
  • Performed testing and quality control using approved laboratory procedures and instrumentation.
  • Contributed to a safe working environment by consistently following established safety procedures and guidelines within the lab setting.
  • Maintained documentation on tests performed in lab.
  • Performed routine lab and department maintenance to keep area clean and orderly.
  • Completed quality documents and input and saved quality data in appropriate locations.
  • Performed complex analyses using various instrumentation, delivering reliable data for informed decisionmaking.
  • Prepared reagents, media and solutions to use for laboratory testing and analysis.
  • Maintained safe, tidy and organized laboratory environment for accurate test results.

Education

Master of Science - Management

Polytechnic University
Brooklyn, NY

Bachelor of Science - Chemistry

Long Island University
Brooklyn, NY

Associate of Applied Science - Chemical Technology

New York City College of Technology
Brooklyn, NY

Skills

  • Regulatory submissions
  • Regulatory strategy
  • Labeling compliance
  • Training and mentoring
  • Document review
  • FDA regulations
  • Document control
  • Technical documentation
  • Teamwork and collaboration
  • Labeling requirements

Accomplishments

  • Collaborated with team of ten professionals in the development of an automated information management system for product specification and standard testing procedures
  • Achieved the successful creation of the automated information management system through effectively collaboration with team members
  • Achieved the targeted results by participating in the final design and implementation of the custom STAIRS program for document management

Interests

I enjoy taking road trips to historic, natural and cultural sites I also enjoy watching all major sports My family and I are big fans of everything Disney, and we hold annual passes to Walt Disney World My interests also include touring microbreweries

Timeline

Senior Regulatory Affairs Associate

Pfizer
08.1987 - 08.2007

Quality Assurance Inspector

Pfizer
04.1982 - 08.1987

Technical Information Coordinator

Pfizer
04.1975 - 04.1982

Laboratory Technician

Pfizer
06.1970 - 04.1975

Master of Science - Management

Polytechnic University

Bachelor of Science - Chemistry

Long Island University

Associate of Applied Science - Chemical Technology

New York City College of Technology

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John Michael Rondello