Manager, Regulatory Affairs

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

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

• Provide expert regulatory advice and contribute to regulatory project work • Compile, manage and track regulatory submissions accurately • Prepare regulatory sections of proposals and feasibility reports, regulatory costing and budgets • Attend bid defense meetings • Develop department work practices and company initiatives • Plan, organize, compile progress and submit regulatory submissions with the Regulatory Affairs Director • Coordinate and manage regulatory and ethics committee submissions and maintain approvals across EMEA, Asia Pacific and Latin America • Monitor changing regulatory legislative requirements and maintain the regulatory intelligence database • Contribute to technical documentation such as IMPDs and IBs • Review labels, patient information sheets, diary cards and other documentation for compliance • Communicate submission status to Sponsors, Project Managers, CRAs, Medical and Scientific Affairs staff • Comply with SOPs, ICH GCP and national regulations • Foster professional relationships with internal and external contacts • Train, coach and mentor junior staff and potentially line manage them • Deputize for the Regulatory Affairs Director • Perform other assigned duties

🎯 Requirements

• Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience • Previous experience within the pharmaceutical/CRO industry • Proven leadership and organizational management skills • Strong planning, strategizing, managing, monitoring, scheduling and critiquing skills • Excellent written and verbal communication skills • Strong interpersonal skills in a fast-paced, deadline-oriented and changing environment • Ability to handle multiple tasks in a fast-paced and constantly changing environment • Ability to exercise sound judgment and make decisions independently • Excellent self-motivation skills • Proficiency in Microsoft Word, Excel and PowerPoint • Expert knowledge of ICH GCP • Expert knowledge of the EU Clinical Trials Directive and national regulations, including CTAs, amendments, urgent safety measures and end-of-trial notifications • Expert knowledge of drug development

🏖️ Benefits

• Diverse and inclusive work environment • Accessible leaders and cohesive, supportive teams • Training, coaching and mentoring opportunities • Equal employment opportunities • Exceptional employee experiences • Opportunity to work with a global team