Regulatory Coordinator, Guayaquil

We are looking for a detail-oriented and proactive Regulatory Coordinator to support regulatory operations and ensure compliance with national and international standards.
This role is critical in managing regulatory processes, coordinating clinical study documentation, and liaising with health authorities.
Key Responsibilities
* Lead regulatory submissions and documentation for clinical studies
* Manage regulatory procedures
* Track and follow up on submitted clinical studies and regulatory applications
* Request and manage regulatory documentation from study sites, investigators, and coordinators
* Support regulatory strategy, registrations, and technical/commercial processes
* Maintain accurate and organized regulatory documentation and archives
* Ensure compliance with applicable national and international regulations (GMP, GCP, etc.)
Requirements:
? 2–5 years of experience in regulatory roles
? Strong knowledge of regulatory processes (non-negotiable)
? Hands-on experience with ARCSA
? Advanced English (you'll be interviewed in English)
? Experience in clinical studies and regulatory submissions is a plus
? Highly organized, proactive, and detail-driven
Key Competencies:
- Strong organizational and time management skills
- Attention to detail and accuracy
- Collaboration and teamwork
- Proactive mindset and problem-solving skills
- Ability to influence and communicate effectively with stakeholders
What We Offer
Competitive salary, professional growth opportunities, positive work environment, and private medical insurance