Job Description
📋 Description Regulatory submission support to ensure accurate preparation, organization, and delivery of Assist with preparation, review, formatting, and organization of clinical and CMC submissions and Compile and package submissions using electronic platforms for compliance. Assemble, publish, and submit regulatory docs to agencies including amendments and annual reports. Manage submission processes: accounts, tracking, reconciliation, and issue resolution. Maintain regulatory archives and documentation systems for quick access. 🎯 Requirements Bachelor’s degree in biology, veterinary medicine, regulatory affairs, life sciences, or related 3–5 years of regulatory operations experience in human health, animal health, biotech, pharma, or Experience preparing, formatting, packaging, and submitting regulatory docs. Hands-on experience with electronic regulatory submission systems, including FDA processes. Knowledge of IND/INAD, NDA/NADA, biologics submissions, meeting requests, supplements, and related Understanding of regulatory documentation standards and lifecycle management. 🎁 Benefits Competitive salary range: $110,000 - $160,000. Company equity options for new hires. Full health insurance (medical, dental, vision) for employees and dependents. $1,000 home office equipment stipend. $1,200 annual learning & development budget. $250 monthly wellness budget.
