Regulatory Affairs Manager LATAM
Há 4 dias
We are seeking an experienced Regulatory Affairs Manager to lead our team in Latin America, ensuring compliance with local and international regulations.
About UsIntrials 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.
- 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.
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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