Sr Manager/Assoc Director, Regulatory Operations
New
E
ErascaPrecision oncology
Fully remote anywhere in the United StatesFull-TimeManager
SalaryThe anticipated salary range for this position is $185,000 to $200,000. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.
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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.
- Sound knowledge of drug development strategies and regulations.
- Hands-on experience with regulatory information management or electronic document management systems.
- Experience with health authority question and commitment tracking.
- Strong project management skills, including managing deadlines, changing requirements, multiple priorities, and operational risks.
- Experience with document formatting and 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.
- Experience supporting or preparing a marketing application (NDA/BLA/MAA) or a major amendment in a lead operational role is preferred.
- Experience in a small or mid-sized company is preferred.
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 quality-control reviews of study TMFs and resolve documentation gaps.
- Establish and maintain regulatory document templates, formatting standards, naming conventions, submission-ready document requirements, and archival practices.
- Maintain organized, inspection-ready regulatory repositories and archives.
- Support or lead management of the Regulatory department budget, including forecasts, invoices, and payment approvals.
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