Regulatory Affairs Associate

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Create, publish, and maintain the publishing of regulatory submissions to international health authorities in accordance with set standards, requirements, and organizational commitments.

• Ensure that all submissions are produced in high-quality, compliant formats.

• Carry out related tasks as necessary and offer support to both internal and external stakeholders.

⛳️ Requirements

• 1–3 years of experience in regulatory publishing or document management within the pharmaceutical sector.

• Familiarity with XML or other structured document formats.

• Basic understanding of eCTD structure and electronic submission requirements for global health authorities (FDA, EMA, Health Canada, etc.).

• Proficiency in regulatory publishing systems such as Veeva, Extedo, Insight, DXC, or similar platforms.

• Strong knowledge of eCTD structure, submission standards, and relevant regulatory guidelines.

• Exceptional attention to detail with the capability to handle complex documentation and meet stringent deadlines.

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off

• Flexible work arrangements

• Professional development