ErascaHiring

Sr Manager/Assoc Director, Regulatory Operations

  • Remote, United States
  • Lead
  • Posted 7 days ago
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In one line

Sr Manager/Assoc Director, Regulatory Operations is a lead remote role in the United States at a clinical-stage precision oncology company.

About the role

Reporting to the chief regulatory affairs officer, the role covers the whole portfolio: a regulatory information management system, submission planning, records, publishing and health authority correspondence.

At a glance

Pay
Not stated in the posting
Remote scope
Remote, United States
Seniority
Lead
Skills
Regulatory Operations, RIM, EDMS, NDA, BLA, MAA, Smartsheet, Microsoft 365
Posted
22 Oct 2026
Last checked
29 Oct 2026

What you will do

  • Work with regulatory leads and other teams to define submission content, owners, timelines and deliverables, tracking progress and risks
  • May independently lead standardized submissions such as DSURs and IBs
  • Keep submission records, correspondence and commitments accurate and update trackers on time
  • Run periodic QC reviews of study TMFs and close documentation gaps
  • Set document templates, formatting and naming standards, and keep inspection-ready repositories and archives
  • May manage the department budget, including forecasts, invoices and payment approvals

What they look for

  • Six or more years in regulatory operations or a closely related field, ideally at a small or mid-sized company
  • Knowledge of drug development strategy and regulations
  • Experience in a lead operational role on a marketing application (NDA, BLA or MAA) or a major amendment preferred
  • Strong project management across deadlines, shifting requirements and operational risk

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Questions about this job

Can I do this job remotely, and from which countries?

Yes. The posting lists Sr Manager/Assoc Director, Regulatory Operations as a remote role for candidates in the United States.

What does this job pay?

The posting does not state a salary, so there is no figure to quote.

What experience is needed?

It is a lead role. The posting asks for: six or more years in regulatory operations or a closely related field, ideally at a small or mid-sized company; knowledge of drug development strategy and regulations; experience in a lead operational role on a marketing application (NDA, BLA or MAA) or a major amendment preferred. Skills it names include Regulatory Operations, RIM, EDMS, NDA.

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