Regulatory Affairs Manager LATAM

Há 4 dias


Belo Horizonte, Minas Gerais, Brasil Intrials Clinical Research Tempo inteiro
Job Overview

We are seeking an experienced Regulatory Affairs Manager to lead our team in Latin America, ensuring compliance with local and international regulations.

About Us

Intrials Clinical Research is a pioneering Contract Research Organization (CRO) dedicated to delivering innovative solutions for the pharmaceutical industry. Our mission is to leverage cutting-edge technology and expertise to drive successful clinical trials.

Responsibilities
  • Manage the regulatory strategy for our clinical trials in Latin America, collaborating with internal stakeholders and external partners.
  • Develop and maintain relationships with key regulatory bodies, including LECs and MOH, to ensure seamless trial execution.
  • Support the development of study protocols, informed consent forms, and other regulatory documents.
  • Oversee the preparation and submission of ethics and regulatory submissions for clinical trials.
  • Maintain accurate records of regulatory correspondence and updates on changing regulations.
  • Collaborate with cross-functional teams to ensure compliance with ICH-GCP guidelines and Intrials' SOPs.
Requirements
  • Bachelor's degree in a health-related field (Pharmacist, Nursing, etc.).
  • Minimum 5 years of experience in Regulatory Affairs for clinical trials in the pharmaceutical industry or CROs.
  • Demonstrated knowledge of local and international regulations applicable to clinical trials in Latin America.
  • Experience with clinical trials procedures for phases I-III and ICH-GCP.
  • Proficient in Microsoft Office, Excel, and Adobe Acrobat software.
  • Excellent communication and project management skills.
Why Choose Us?

We offer a competitive salary package ($80,000 - $110,000 per year), opportunities for growth and development, and a dynamic work environment. If you are passionate about science and committed to excellence, we encourage you to apply.



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