Regulatory Officer

🔥 0 minutes ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.

📋 Description

• Prepare clinical trial documents for Regulatory and Ethics submissions • Communicate with regulatory authorities and support communication with ethics committees, project teams and vendors on regulatory-related matters • Review translations of essential documents subject to clinical trial submission • Track the regulatory project documentation flow • Review documents to greenlight IP release to sites • Manage safety reporting to authorities • Deliver regulatory training to project teams • Assist with feasibility research and business development requests

🎯 Requirements

• College/University degree or an equivalent combination of education, training and experience • Prior experience with clinical trial submissions to ANVISA in Brazil • Prior experience with regulatory activities for clinical trials • Full working proficiency in English and Portuguese • Spanish is a plus • Proficiency in MS Office applications • Detail-oriented • Ability to learn, plan and work in a dynamic team environment • Communication, collaboration, and problem-solving skills

🏖️ Benefits

• Excellent and flexible working conditions • Extensive training • Friendly, collegial team • Competitive salary and benefits package • Opportunities for personal and professional growth • Remote work availability

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