Worldwide Clinical Trials
1001 - 5000 employees
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.
Director, Regulatory Pre-Award Strategy
🔥 0 minutes ago
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Worldwide Clinical Trials
1001 - 5000 employees
🧬 Biotechnology
💊 Pharmaceuticals
⚕️ Healthcare Insurance
Biotechnology • Pharmaceuticals • Healthcare Insurance
Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.
📋 Description
• Accountable for senior-level leadership in establishing operational strategy for global regulatory affairs. • Oversees delivery and performance of regulatory affairs activities. • Provides expert regulatory advice and contributes to project work for internal and external customers. • Responsible for planning and oversight of regulatory affairs activities, ensuring high quality and timely delivery. • Engages in business development activities by contributing to proposals and bid defense meetings. • Stays informed about changing regulatory affairs requirements and ensures team training. • Responsible for submission/approval of regulatory dossiers and maintaining compliance with regulations.
🎯 Requirements
• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR… • Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and eight years’ experience within clinical research (e.g. CRA, Reg Affairs.) • Minimum 10 years within pharmaceutical/CRO industry, with demonstrated senior level regulatory or clinical start-up experience • Proficient in cross-cultural communication and proficient in both spoken and written English.
🏖️ Benefits
• Competitive salary • Flexible working hours • Professional development opportunities • Inclusive workplace culture
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