Associate, Regulatory Affairs

We're looking for a detail-oriented and driven Associate, Regulatory Affairs to join our client's Regulatory Affairs team. This is a fantastic opportunity to contribute to high-quality FDA submissions and help bring innovative therapies to market. What You'll Do: Support the preparation, review, and submission of regulatory documents including NDAs, amendments, supplements, and annual reports. Collaborate cross-functionally to gather and verify documentation for timely submissions. Review technical documents for accuracy and regulatory compliance. Draft clear and concise responses to FDA inquiries under supervision. Track and maintain regulatory databases and spreadsheets. Monitor regulatory changes and assess their impact on the business. Provide administrative support and manage communications with regulatory agencies as needed. What You Bring: Bachelor's degree in a life science discipline. 3 years of experience in the pharmaceutical industry, with at least 1-2 years in regulatory affairs. Strong understanding of FDA guidelines and regulatory requirements. Excellent written and verbal communication skills. High attention to detail, strong analytical thinking, and sound judgement. Ability to manage multiple priorities in a fast-paced environment.

Location: Madrid, Community of Madrid, ES

Posted Date: 8/23/2025