Regulatory Affairs Associate

📋 Description

• Create, publish, and facilitate the distribution of regulatory submissions to international health authorities, ensuring adherence to established standards, requirements, and organizational commitments.

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

• Conduct related activities as necessary and offer assistance to both internal and external stakeholders.

⛳️ Requirements

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

• Experience 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 grasp of eCTD structure, submission standards, and relevant regulatory guidelines.

• Exceptional attention to detail and the ability to manage complex documentation while meeting tight deadlines.

• Familiarity with end-to-end submission lifecycle maintenance processes.

• Comprehensive knowledge of FDA and international regulatory agency requirements.

• Previous experience with document control or compliance-driven workflows.

• Strong background in document preparation and formatting.

• Proficiency in Microsoft Word and Adobe Acrobat for document formatting, hyperlinking, and submission preparation.

• Capability to work effectively in a cross-functional team environment and handle multiple tasks under stringent deadlines.

• Quick learner of new software tools and systems.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Remote work options