René Ramírez
Mexico City
Summary
Experienced with specialized task execution and strategic implementation. Utilizes effective problem-solving techniques to enhance operational processes. Track record of fostering team collaboration and ensuring project success.
Overview
6
6
years of professional experience
Work History
Senior Country Approval Specialist
Thermo Fisher Scientific
04.2024 - Current
- On December 8, 2021, Thermo Fisher Scientific completed the acquisition of PPD.
- Prepares, reviews, and coordinates local regulatory submissions (MoH, EC) in alignment with the global submission strategy. Coordinates with internal functional departments to ensure various site start-up activities were aligned with submission activities and mutually agreed upon timelines.
Country Approval Specialist
Thermo Fisher Scientific
11.2021 - 03.2024
- Prepares, reviews, and coordinates local regulatory submissions (MoH, EC) in alignment with the global submission strategy. Coordinates with internal functional departments to ensure various site start-up activities were aligned with submission activities and mutually agreed upon timelines.
Site Start Up & Regulatory Specialist I
Syneos Health
04.2021 - 10.2021
- Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time. Compiles and/or reviews essential document packages for site activation and may also be involved in essential document collection from site.
Regulatory Affairs Assistant
Infinite
04.2019 - 08.2020
- Responsible for administration and monitoring of regulatory projects, remote monitoring, management of national health regulation.
Education
B. Sc. - Chemical Engineering
Universidad Nacional Autónoma de México
12.2016
Skills
- Customer relations
- Expert problem solving
- Analytical thinking
- Documentation management
- Management collaboration
- Proficient in Veeva Vault
- Emergency response
- Expert in Activate
- Team collaboration
- Coaching and mentoring
- Continuous improvement
- Risk management
Language(s)
Native Tongue: Spanish
Proficient: English, German
Additional Relevant Experience
- Computer Experience
- MS Word, MS Excel, MS PowerPoint
- CTMS, Activate
- ETMF (Veeva Vault)
Timeline
Senior Country Approval Specialist
Thermo Fisher Scientific
04.2024 - Current
Country Approval Specialist
Thermo Fisher Scientific
11.2021 - 03.2024
Site Start Up & Regulatory Specialist I
Syneos Health
04.2021 - 10.2021
Regulatory Affairs Assistant
Infinite
04.2019 - 08.2020
B. Sc. - Chemical Engineering
Universidad Nacional Autónoma de México
Similar Profiles
Emily RobinsonEmily Robinson
Pharmacy Technician II at Fisher Bioservices, Thermo Fisher ScientificPharmacy Technician II at Fisher Bioservices, Thermo Fisher Scientific
Rodney CrowderRodney Crowder
Senior Field Service Supervisor at Thermo Fisher Scientific Inc.Senior Field Service Supervisor at Thermo Fisher Scientific Inc.
NEHA SALUNEHA SALU
Scientist at Thermo Fisher Scientific Inc.Scientist at Thermo Fisher Scientific Inc.
DENITSA FILIPOVA ARNAUDOVADENITSA FILIPOVA ARNAUDOVA
Senior BI Analyst at PPD, Part of Thermo Fisher ScientificSenior BI Analyst at PPD, Part of Thermo Fisher Scientific
Sergio RojasSergio Rojas
Vice President of Business Development at La HausVice President of Business Development at La Haus