Renata Rodríguez

Regulatory Affairs professional with over two years of experience in clinical trials within pharmaceutical and CRO environments. Experienced in regulatory submissions, document management, and compliance with local and international regulations, including GCP. Strong attention to detail, proactive communication skills, and experience working with cross-functional teams.

GMASE México Group-Regulatory & Start-Up Specialist at PPD México S.A. de C.V. (Thermo Fisher Scientific) (2024-01 – Present)

Regulatory and start-up activities for clinical trials in collaboration with GSK México.

• Regulatory and start-up activities for clinical trials in collaboration with GSK México.
• Preparation and submission of regulatory documentation to ethics committees and authorities.
• Tracking of submissions, approvals, and regulatory timelines.
• Coordination with cross-functional teams to ensure GCP compliance.

Clinical Regulatory Intern at Novo Nordisk México (2023-01 – 2024-12)

Clinical regulatory support for pharmaceutical trials.

• Supported regulatory submissions for clinical trials.
• Preparation and maintenance of regulatory binders and essential documents.
• Communication with ethics committees and internal stakeholders.

Quality Management System – Pharma, Food & Nutrition at IMCD México (2022-01 – 2023-12)

Quality management system support for pharmaceutical, food and nutrition sectors.

Research Assistant at La Salle University Mexico – Research Group (2022-01 – 2022-12)

Design and synthesis of heterocyclic compounds with potential therapeutic activity.

• Design and synthesis of heterocyclic compounds with potential therapeutic activity.

Pharmaceutical Chemical Biologist in Pharmaceutical Chemistry – La Salle University México (2019-2023)