Senior Manager, Regulatory Affairs

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

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

• Review study budgets and costing about contract negotiation, participate in business development activities, prepare regulatory sections of proposals and feasibility reports and attend bid defense meetings to meet business needs • Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions and ensure accurate compilation, management and tracking of submissions • Provide expert regulatory advice and contribute to regulatory project work. Effectively communicate status of submissions with the Sponsor, Project Manager, CRAs, and Medical & Scientific Affairs staff. • Contribute towards the preparation of technical documentation such as IMPDs and IBs, review and make recommendations on all relevant documentation to ensure compliance with ICH GCP & country-specific requirements • Provide training, coaching, and mentoring to junior members of staff, may be required to line manage junior members of staff

🎯 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 of experience within clinical research (e.g., CRA, Reg Affairs) • Minimum 5-7 years within the 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 budget • Home office setup allowance • Global team events