U.S. Regulatory Associate - Obesity

Job Summary

Supporting the U.S. regulatory execution for obesity-related products, the full-time remote U.S. Regulatory Associate - Obesity will manage regulatory submissions, maintain compliant documentation, and facilitate cross-functional collaboration to ensure effective health authority engagement.

Key responsibilities

• Coordinate and execute U.S. regulatory submissions in compliance with corporate standards and FDA requirements
• Drive submission readiness by tracking timelines and ensuring deliverables are complete and submitted on time
• Maintain regulatory documentation and records, including preparation and archiving of submission content and agency communications

Required qualifications

• Master's degree in biology, life science, health science, or regulatory science; or Bachelor's degree with 2 years of related experience; or Associate's degree with 6 years of related experience; or High school diploma with 8 years of related experience
• Experience in a regulated industry such as biotech, pharma, or clinical research
• Experience supporting programs in Obesity, Diabetes, or related metabolic diseases
• Familiarity with document management and archiving practices in a regulated setting
• Strong organizational skills with the ability to manage multiple activities and timelines