Senior Specialist, Regulatory Operations

📋 Description

• Manage routine regulatory submissions, including INDs, CTAs, application lifecycle submissions
• Support complex or high-priority filings under the guidance of the responsible Regulatory
• Maintain submission plans, content trackers, milestones, delivery dates, and readiness status in
• Coordinate with document owners to confirm content handoffs, track outstanding actions, communicate
• Prepare submission-ready Word and PDF documents, including formatting, conversion, bookmarking
• Compile, publish, and validate eCTD and non-eCTD submission packages using approved tools and

🎯 Requirements

• Bachelor’s degree in life sciences or a related discipline.
• Master’s degree in Regulatory Affairs is highly desirable.
• At least 4 years of regulatory operations experience in the pharmaceutical or biotechnology
• Working knowledge of eCTD lifecycle management, applicable FDA and ICH technical standards
• Strong Microsoft Word and Adobe Acrobat skills, including document formatting, PDF preparation
• Experience using a regulatory information management system (RIM) or a comparable validated

🎁 Benefits

• Annual salary range: $122,000–$143,000 USD.
• Additional compensation: Total compensation may include a bonus, stock, benefits, and other
• Location-based compensation: Final compensation depends on experience, skills, certifications, work
• Remote work: The position is listed as remote within the United States.