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Regulatory Affairs Specialist

2 months ago

Australia Worldwide Clinical Trials - APAC Full time
About the Role

At Worldwide Clinical Trials - APAC, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Site Activation and Regulatory department, you will play a critical role in supporting the planning, initiation, and tracking of documents required for regulatory submissions.

Key Responsibilities
  • Liaise with Site Activation & Regulatory (SAR) colleagues to drive the planning, organization, compilation, progress, tracking, and submission of regulatory submissions on a timely basis and with a consistently high level of quality.
  • Act as a contact point for translation review of submissions documents such as applications, synopses, informed consent forms, labels, etc.
  • Maintain country-specific patient information sheet and consent form customization text, maintain country-specific drug labeling information, and Country Intelligence Pages.
  • Review and make recommendations on all relevant documentation, such as labels, patient information sheets, diary cards, etc., to comply with ICH GCP and country-specific requirements.
Requirements
  • Organizational and time management skills.
  • Aptitude for planning, strategizing, managing, monitoring, scheduling, and critiquing skills.
  • Strong written and verbal communication skills to clearly and concisely present information in English and local language.
  • Strong ability to handle multiple tasks in a fast-paced and changing environment.
  • Proficiency in MS-Office applications, including Microsoft Word, Excel, and PowerPoint.
  • Strong understanding of country-level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.
Qualifications
  • A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science.
  • Minimum two years of experience in clinical research, preferably in site activation and/or regulatory-related function.
  • Previous experience within the pharmaceutical/CRO industry.
  • Thorough knowledge of ICH GCP, EU Clinical Trials Directive, and other relevant clinical research conduct guidance.
  • Multilingualism preferred; fluent in local language; working knowledge of English.