Regulatory Affairs Specialist with over 10 years of experience in the pharmaceutical industry across LATAM. Proven track record in leading end-to-end regulatory strategies, dossier preparation, and compliance coordination in highly regulated markets. Skilled in labeling processes, quality audits, and cross-functional collaboration. Known for analytical thinking, ethical commitment, and regional expertise in Central America, the Caribbean, and South America.
Hi, I’m
RENZO ALDHAIR CHÁVEZ SALAS
Regulatory Affairs Specialist
Panama City
Summary
Overview
11
years of professional experience
3
Languages
Work History
GRUNENTHAL S.A. PANAMA
REGULATORY AFFAIRS SPECIALIST
08.2021 - Current
Job overview
- E2E project leadership in the development of regulatory strategies. Creation of files for new registrations, renewals, and post-registration change files. Coordination of regulations in Central America, the Dominican Republic, and the Caribbean Islands.
- Led regulatory submissions for product approvals, ensuring compliance with local and international standards, enhancing market access.
- Developed and maintained regulatory documentation, streamlining processes and improving accuracy in submissions and reporting.
- Collaborated with cross-functional teams to interpret regulatory requirements, facilitating efficient project execution and compliance adherence.
- Conducted thorough assessments of product labeling and advertising, ensuring alignment with regulatory guidelines and reducing compliance risks.
FRESENIUS MEDICAL CARE PANAMÁ S.A.
Regulatory Affairs Analyst
06.2019 - 08.2021
Job overview
- Development and follow-up of regulatory strategies, creation of dossiers for products requiring re-registration, documentary follow-up of renewals and post-registration changes. Coordination of regulations in Central America, the Dominican Republic, Cuba, and Venezuela.
- Provided training and mentorship to junior staff on regulatory processes, improving team knowledge and enhancing submission quality.
- Evaluated changes in regulatory policies, proactively adapting strategies to maintain compliance and mitigate potential risks to operations.
- Managed relationships with regulatory bodies, fostering effective communication and expediting the approval process for critical projects.
- Implemented continuous improvement initiatives within the regulatory framework, resulting in enhanced efficiency and reduced submission timelines.
JANSSEN CILAG S.A. PANAMA
Regulatory Affairs Analyst
10.2017 - 06.2019
Job overview
- Responsible for the review, submission, and implementation of all processes related to labeling, packaging, and labeling of products, coordination for compliance with the implementation schedule of monographs and inserts. Assistance in the preparation of dossiers for new molecules. Coordination of regulations in Central America, the Caribbean, the Dominican Republic, and Venezuela.
- Developed and implemented regulatory strategies to ensure compliance with local and international regulations, enhancing product approval timelines.
- Conducted comprehensive assessments of regulatory submissions, resulting in improved accuracy and efficiency in document preparation and submission processes.
- Collaborated with cross-functional teams to align regulatory requirements with product development, fostering effective communication and project timelines.
- Monitored regulatory changes and trends, providing timely updates and recommendations that supported strategic decision-making within the organization.
ABBOTT LABOTORIOS S.A. GUATEMALA
Quality Assurance Analyst
05.2016 - 10.2017
Job overview
- Responsible for coordinating the monitoring of internal audits of compliance with quality standards, raising observations and conducting audits to suppliers of the company. Training, management and updating of local standard procedures. Management and follow-up of claims related to the quality of imported products.
- Led training sessions on regulatory compliance for internal teams, improving overall understanding and adherence to industry standards.
- Analyzed complex regulatory guidelines to identify potential impacts on product development, facilitating proactive adjustments to project plans.
- Assisted in the preparation of responses to regulatory inquiries, ensuring timely communication and maintaining strong relationships with regulatory authorities.Qu
- Supported the development of internal compliance databases, streamlining access to regulatory documents and enhancing organizational efficiency.
LABORATORIOS PORTUGAL S.R.L.E PERU
Quality Control Analyst
01.2015 - 12.2015
Job overview
- Analyst assistant in quality control laboratory, inspection and control report in production area, control and analysis of packaging and labeling materials, chemical and physical testing of raw material for production.
- Developed and executed comprehensive test plans, ensuring adherence to quality standards and regulatory compliance across all products.
- Collaborated with cross-functional teams to troubleshoot and resolve defects, enhancing product reliability and user satisfaction.
- Designed and implemented automated testing frameworks, significantly improving testing efficiency and reducing time-to-market for new releases.
- Conducted thorough root cause analysis on quality issues, leading to the identification of process improvements and enhanced product quality.
Education
Santa Maria Catholic UniversityArequipa
Bachelor's Degree from Pharmacy and Biochemistry
University Overview
RESEARCH AND PRESENTATIONS
RESEARCH AND PRESENTATIONS
- 2011 ANTIOXIDANT ACTIVITY OF VITIS VINIFERA (GRAPE) SEED AND PEEL EXTRACT FROM DIFFERENT ZONES OF PERU.
- XXII Peruvian Scientific Congress of Students of Pharmacy and Biochemistry Cusco, 1 - 25.
- (2014) DETERMINATION OF MERCURY, CADMIUM, AND LEAD IN THE MOST CONSUMED FISH IN THE REGION. Arequipa.
- XXIV Peruvian Scientific Congress of Students of Pharmacy and Biochemistry Juliaca, 1 - 10.
- (2015) ISOLATION OF ANTITUMOR COMPOUNDS FROM ANNONA MURICATA (SOURSOP) LEAVES AND THEIR APOPTOTIC EFFECT ON PC-3 PROSTATE CANCER CELLS.
- XXV Peruvian Scientific Congress of Students of Pharmacy and Biochemistry Ayacucho, 1 - 22.
- (2024) XXXII Peruvian Scientific Congress of Students of Pharmacy and Biochemistry Ayacucho - Guest speaker - Pharmaceutical Industry theme
Skills
Regulatory strategy development
undefinedTimeline
REGULATORY AFFAIRS SPECIALIST
GRUNENTHAL S.A. PANAMA
08.2021 - Current
Regulatory Affairs Analyst
FRESENIUS MEDICAL CARE PANAMÁ S.A.
06.2019 - 08.2021
Regulatory Affairs Analyst
JANSSEN CILAG S.A. PANAMA
10.2017 - 06.2019
Quality Assurance Analyst
ABBOTT LABOTORIOS S.A. GUATEMALA
05.2016 - 10.2017
Quality Control Analyst
LABORATORIOS PORTUGAL S.R.L.E PERU
01.2015 - 12.2015
Santa Maria Catholic University
Bachelor's Degree from Pharmacy and Biochemistry