Senior Associate Specialist, Regulatory Operations

📋 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.