David Esteban Vernaza Martin
Bogotá
Summary
Driven Regulatory Associate from Navitas Inc, adept in legal and regulatory research, showcased through strategic risk evaluations and compliance enhancements. Excelled in teamwork and collaboration, leading to effective cross-functional partnerships and streamlined regulatory submissions. Achieved significant process improvements, underlining a strong focus on results and attention to detail.
Overview
3
3
years of professional experience
Work History
Regulatory Associate for CAC-CA
Navitas Inc
Bogotá, Colombia (Remote)
06.2022 - Current
- Evaluated potential risks associated with new products or markets, providing strategic recommendations to executive leadership.
- Monitored changes in regulatory requirements, updating internal processes to maintain compliance.
- Review, interpret and audit the data provided to establish the system/tool required to be populated in line with current SOP and resolve errors to ensure the integrity of it.
Support global/local teams with data management for CMC, Labeling, Artwork and CTA of CAC, Brazil, México and Canada. - Trained staff members on relevant regulations and best practices, increasing overall departmental knowledge base.
- Collaborated with cross-functional teams to ensure timely submission of high-quality regulatory documents.
- Developed strong relationships with regulatory authorities, facilitating effective communication channels.
- Maintained and archived regulatory paperwork.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Recommended improvements to processes.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
- Developed or tracked quality metrics.
CDM Jr. Associate for CAC-CA
PTA-Pfizer Colombia
Bogotá, Colombia (Remote)
07.2021 - 06.2022
- Strengthened collaborative efforts among teammates by facilitating open dialogues during group discussions.
- Maintained confidentiality while handling sensitive information related to client accounts or legal matters.
- Supported senior associates in managing client relationships by scheduling meetings, taking minutes, and following up on action items.
- Streamlined regulatory submissions process for faster approval times and reduced company risk exposure.
- Supported acquisition activities by assessing target companies'' regulatory compliance status and advising on integration strategies postacquisition.
Education
Bachelor of Science - Pharmacist
Universidad Nacional De Colombia
Bogotá, Colombia12.2021
Skills
- Legal Research
- Regulatory research
- Document Review
- Policy analysis
- Regulatory Policies
- Information Verification
- International Regulations
- Data Verification
- Technical Documentation
- Teamwork and Collaboration
- Problem-Solving
- Attention to Detail
- Multitasking Abilities
Languages
Spanish
Native language
English
Advanced
C1
Timeline
Regulatory Associate for CAC-CA
Navitas Inc
06.2022 - Current
CDM Jr. Associate for CAC-CA
PTA-Pfizer Colombia
07.2021 - 06.2022
Bachelor of Science - Pharmacist
Universidad Nacional De Colombia