Regulatory Officer

🕒 3 days ago

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🔬 Science

Healthcare Insurance • Pharmaceuticals • Science

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 submission dossiers for Regulatory and Ethics Authorities, with a specific focus on Canadian and US regulatory submissions, including Import and Export license applications • Communicate with regulatory authorities, 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 in North America • Full working proficiency in English and French, native French speaker competency required, US Spanish speaker competency beneficial • Proficiency in MS Office applications • Detail-oriented • Ability to learn, plan and work in a dynamic team environment • Communication, collaboration, and problem-solving skills