Regulatory Affairs and Patient Safety

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Regulatory Affairs and Patient Safety professional based in Brazil.

This role sits within a global clinical development environment focused on ensuring that life-changing therapies are developed, approved, and monitored with the highest standards of safety and regulatory compliance. You will contribute directly to improving patient outcomes by supporting regulatory submissions, product compliance activities, and pharmacovigilance processes across multiple therapeutic areas. The position offers exposure to both regulatory affairs and patient safety functions, allowing you to work across labeling, submissions, health authority interactions, and safety monitoring activities. You will collaborate with cross-functional teams in a highly regulated, mission-driven environment where accuracy, scientific rigor, and patient impact are central. The role also provides flexibility through remote work, enabling you to contribute to global healthcare innovation while maintaining work-life balance. This is an opportunity to play a meaningful part in advancing clinical research and ensuring therapies reach patients safely and efficiently.

Accountabilities:

• Support regulatory affairs activities including labeling operations, labeling strategy, advertising and promotion compliance, and chemistry, manufacturing, and controls (CMC) documentation.
• Assist in preparing, reviewing, and managing regulatory submissions and documentation to ensure compliance with global health authority requirements.
• Contribute to regulatory operations and publishing activities, ensuring accurate, timely, and compliant submission of dossiers.
• Support interactions with regional and global health authorities, ensuring alignment with regulatory expectations and guidelines.
• Participate in patient safety activities including the review, documentation, tracking, and analysis of safety events and signals.
• Identify trends and risks in patient safety data and contribute to continuous process improvement initiatives.
• Collaborate with cross-functional teams including clinical, regulatory, and pharmacovigilance stakeholders to ensure integrated delivery.
• Ensure adherence to applicable regulatory standards, internal procedures, and global compliance frameworks.
• Support the maintenance of high-quality documentation and contribute to inspection readiness activities.

Requirements:

• Experience in regulatory affairs, pharmacovigilance, or patient safety within the pharmaceutical, biotechnology, or clinical research industry.
• Strong understanding of regulatory processes, clinical development lifecycle, or drug safety monitoring frameworks.
• Familiarity with global health authority requirements and regulatory compliance standards.
• Experience preparing, reviewing, or supporting regulatory submissions or safety reports.
• Strong analytical skills with attention to detail and ability to interpret complex scientific and regulatory data.
• Excellent written and verbal communication skills for cross-functional and external stakeholder interaction.
• Ability to work independently while collaborating effectively in global, matrixed teams.
• Strong organizational skills with the ability to manage multiple priorities in a regulated environment.
• Degree in life sciences, pharmacy, medicine, or a related scientific discipline is preferred.
• Exposure to global clinical research environments or CRO settings is an advantage.

Benefits:

• Fully remote work flexibility across Brazil with global collaboration opportunities.
• Competitive compensation aligned with industry standards in clinical research and regulatory professions.
• Opportunity to contribute directly to improving patient safety and global health outcomes.
• Exposure to international regulatory frameworks and global pharmaceutical development programs.
• Career development opportunities within a leading clinical research environment.
• Collaborative and mission-driven culture focused on scientific excellence and patient impact.
• Work-life balance supported through flexible working arrangements.
• Inclusive environment committed to equal opportunity and professional growth.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1