Worldwide Clinical Trials
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.
Regulatory Affairs Specialist, Remote
August 13
Worldwide Clinical Trials
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.
đź“‹ Description
• Regulatory Affairs is pivotal in navigating the regulatory landscape, ensuring the success of diverse clinical trials. • Submissions leadership to regulatory authorities, coordination with ethics committees across EMEA, Asia Pacific, and Latin America, ensuring compliance with evolving regulations. • Develop and approve innovative medical products, support business development, and advise on contract negotiations. • Mentor junior staff; review key documentation for global regulatory standards; keep stakeholders informed throughout the submission process. • What you will do: Liaise with SAR colleagues to plan, organize, compile, progress, track and submit regulatory submissions on a timely basis. • May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc. • Provide local QC of submission dossiers prior to dispatch where required. • Communicate status and action plans to SAR Lead and project team; identify risks and mitigation strategies. • Foster professional relationships to ensure expeditious submission/approval of regulatory dossiers. • Maintain country-specific patient information sheet and consent form customization text; drug labeling information; Country Intelligence Pages. • Be familiar with SOPs, ICH GCP and applicable regulations; stay informed of changing regulatory requirements. • Advise SAR project team on regulatory strategies; review and recommend on documentation to comply with ICH GCP & country requirements. • Provide updates and interpretation of new legislation, guidance and directives.
🎯 Requirements
• Degree with a major concentration in medical, biological, physical, health, pharmacy or other related science. • Minimum 2 years of experience in clinical research, in site activation and/or regulatory-related function within a CRO. • To be considered for this role, candidates must have experience with the regulatory process in the UK and under EU-CTR. • Good knowledge of ICH GCP, relevant clinical research conduct guidance and country regulations. • Multilingualism preferred; fluent in local language; working knowledge of English. • Thorough understanding of country-level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel. • Easily adjusts to a changing environment; ability to prioritize and adapt between detailed and strategic activities while maintaining delivery timelines and quality. • Team-oriented work style; seeks and gives guidance to others.
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