Specialist, Regulatory & Site Activation - Brazil - Remote

About the Role

The Regulatory Affairs team at Worldwide Clinical Trials boasts extensive industry experience, with a proven track record of shaping project plans to meet diverse regulatory requirements. As a specialist in this field, you will have the opportunity to work on a wide range of projects, from bioanalytical study requirements to successful marketing applications.

In this role, you will be part of a global team of over 3,500 experts, bright thinkers, dreamers, and doers, all working together to change the way the world experiences CROs. With a strong focus on diversity and inclusion, Worldwide Clinical Trials is committed to enabling professionals from all backgrounds and experiences to succeed.

What You Will Do

• 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
• Act as a contact point for translation review of submission documents such as applications, synopses, ICFs, 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
• Develop and maintain strong relationships with local investigators and key site personnel
• Ensure compliance with ICH GCP, EU Clinical Trials Directive, and other relevant guidance on conducting clinical research
• Collaborate with cross-functional teams to ensure timely and high-quality regulatory submissions
• Provide guidance on regulatory requirements and compliance to internal stakeholders
• Develop and implement regulatory strategies to ensure successful regulatory outcomes

What We Are Looking For

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related sciences
• At least two years of experience in clinical research, preferably in site activation and/or regulatory-related function
• Strong organizational and time management skills, with the ability to prioritize tasks and manage multiple projects simultaneously
• Excellent written and verbal communication skills, with the ability to clearly and concisely present information in English and local language
• 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
• Thorough knowledge of ICH GCP, EU Clinical Trials Directive, and other relevant guidance on conducting clinical research

Nice to Have

• Multilingualism, with fluency in local language and a working knowledge of English
• Experience working in a CRO or pharmaceutical company
• Knowledge of regulatory requirements in Brazil and other countries
• Certification in regulatory affairs or a related field

Benefits and Perks

• Competitive salary and benefits package
• Opportunity to work with a global team of experts in the clinical trials sector
• Professional development and training opportunities
• Flexible working hours and remote work options
• Access to cutting-edge technology and tools
• Recognition and reward for outstanding performance
• Comprehensive health insurance and wellness programs
• Generous paid time off and vacation policy

• Research the company's values and mission to understand their commitment to diversity and inclusion, and be prepared to discuss how your skills and experience align with these values.
• Develop a strong understanding of regulatory requirements in Brazil and other countries, and be prepared to discuss your experience working with these regulations.
• Showcase your ability to work in a fast-paced, dynamic environment, and highlight your skills in project management, time management, and prioritization.
• Emphasize your excellent written and verbal communication skills, and provide examples of how you have effectively communicated complex information to internal stakeholders.
• Prepare to discuss your experience working with cross-functional teams, and highlight your ability to build strong relationships with local investigators and key site personnel.
• Highlight your proficiency in MS Office applications, including Microsoft Word, Excel, and PowerPoint, and be prepared to discuss your experience with other regulatory software and tools.
• Be prepared to discuss your long-term career goals and how this role aligns with your aspirations, and highlight your commitment to ongoing learning and professional development.