Sr Manager/Assoc Director, Regulatory Operations
New
E
ErascaPrecision oncology
Fully remote anywhere in the United StatesFull-TimeDirector
SalaryThe anticipated salary range for this position is $185,000 to $200,000.
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Job Details
- Experience
- 6+ years of relevant experience in Regulatory Operations or a closely related field
- Required Skills
- Project Management
Requirements
- Undergraduate degree required; advanced degree preferred.
- RAC certification is a plus.
- 6+ years of relevant experience in Regulatory Operations or a closely related field.
- Experience in a small or mid-sized company preferred.
- Sound knowledge of drug development strategies and regulations.
- Experience supporting or preparing a marketing application (NDA/BLA/MAA) or major amendment in a lead operational role preferred.
- Hands-on experience with regulatory information management or electronic document management systems and health authority question and commitment tracking.
- Strong project management skills, including managing strategic deadlines, changing requirements, multiple priorities, and operational risks.
- Experience with document formatting, authoring templates, and training colleagues on business processes, RIM or EDMS practices, and submission standards.
- Experience creating operational dashboards or portfolio reporting with Smartsheet, Microsoft 365, or comparable tools.
Responsibilities
- Partner with Regulatory Leads and cross-functional stakeholders to define submission content, responsibilities, timelines, and deliverables.
- Track submission progress, identify risks or dependencies, and drive submission activities to completion.
- Independently lead or coordinate standardized submissions such as DSURs and IBs.
- Maintain regulatory submission records, correspondence, commitments, and associated trackers.
- Support periodic QC reviews of study TMFs and resolve documentation gaps.
- Establish and maintain regulatory document templates, formatting standards, naming conventions, submission-ready requirements, and archival practices.
- Maintain organized, inspection-ready regulatory repositories and archives.
- Support or lead regulatory department budget management, including forecasts, invoices, and payment approvals.
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