Base: $100,706.01 to $110,422.12 usd annually; bon...
Fully remote
Prepare and file a/ndas and supplements
Review technical documents for cgmp compliance
Develop regulatory strategy for complex issues
The Regulatory Specialist is responsible for the on-time filing of high-quality regulatory submissions and post-approval maintenance of regulatory dossiers
Job Summary
The Regulatory Specialist is responsible for the on-time filing of high-quality regulatory submissions and post-approval maintenance of regulatory dossiers.
This role requires demonstrated expertise in preparing complete A/NDAs, Supplements, Amendments, and Annual Reports to the FDA.
The position offers a competitive salary range of $100,706.01 to $110,422.12 USD along with comprehensive benefits including medical, dental, vision, and 401K.
Matching Summary
The Regulatory Specialist is responsible for the on-time filing of high-quality regulatory submissions and post-approval maintenance of regulatory dossiers.
Salary
Base: $100,706.01 to $110,422.12 USD annually; Bonus/Equity: Not specified; Benefits: Medical, dental, vision, life insurance, disability, 401K with company contribution, wellness program
Skills & Requirements
Must-have
Prepare and file A/NDAs and Supplements
Review technical documents for cGMP compliance
Develop regulatory strategy for complex issues
Communicate with FDA and project teams
Manage submission timelines and deadlines
Nice-to-have
Train new regulatory specialists
Share best practices for time management
Support COO office on special projects
Work cross-functionally with manufacturing teams
Key Requirements
Bachelor's degree in Chemistry, Biochemistry, Biology, or Biotechnology
One year of experience in pharmaceutical regulatory affairs
Demonstrated expertise with FDA supplements and amendments