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About Us

Worldwide Clinical Trials, LLC is a leading global contract research organization (CRO) that partners with biotechnology and pharmaceutical companies to create customized solutions that advance new medications from discovery to reality.

Our company's scientific heritage and dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases enable us to develop flexible plans and solve problems quickly for our customers.

We have a talented team of 3,000+ professionals spanning 60+ countries, united in our cause to improve the lives of patients through new and innovative therapies.

Our Culture

We believe that everyone plays an important role in making a world of difference for patients and their caregivers. Our hands-on, accessible leaders and cohesive, supportive teams are committed to enabling professionals from all backgrounds and experiences to succeed.

We prioritize cultivating a diverse and inclusive environment that promotes collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.

The Role

As a Regulatory Affairs Specialist at Worldwide Clinical Trials, LLC, you will be a subject matter expert and primary contact for activities supporting Regulatory Authority submissions in coordination with Site Activation & Regulatory (SAR) colleagues for awarded projects.

You will be responsible for leading the planning, initiating, and tracking documents required for regulatory submissions and communicating status, risks, and actions related to project regulatory activities.

May act in a support role to local CRA with regulatory activities when a dedicated regulatory resource is not present locally. Reports to the Site Activation and Regulatory Lead.

Key Responsibilities

• Liaise with SAR colleagues to drive plan, organize, compile, progress, track, and submit regulatory submissions on a timely basis and with a consistently high level of quality.
• May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, 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 e.g. labels, patient information sheets, diary cards, etc. to comply with ICH GCP & 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.

Education and Experience

• 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.