Remote Associate Director, Regulatory Projects

Ladders

United States

Remote

USD 137,000 - 220,000

Full time

21 hours ago
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Benefits offered by this job

Medical coverage
Dental coverage
Vision coverage
401(k) plan
Pension eligibility
Vacation benefits
FSA

Job summary

Ladders is seeking an Associate Director, Regulatory Project Management to lead planning and coordination of regulatory programs supporting submission readiness and post-approval activities in a global development environment.

You will partner with Regulatory Strategy, cross-functional teams, and health authorities to keep timelines aligned, manage risks, and ensure accurate dossier assembly, disciplined documentation, and sound budget forecasting to drive compliant execution.

Qualifications

  • Bachelor's degree in a scientific or related field.
  • 8+ years of regulatory experience in the pharmaceutical/biotech industry.
  • Strong understanding of regulatory frameworks and compliance requirements.
  • Proficiency with project management tools (e.g., Microsoft Project, Smartsheet).
  • Excellent interpersonal and communication skills.
  • Analytical and problem-solving abilities.
  • Attention to detail for accurate documentation.

Responsibilities

  • Develop and maintain integrated project plans for regulatory submissions and post-approval activities.
  • Serve as the primary regulatory contact for timeline management across multiple functions.
  • Identify, assess, and mitigate project risks with contingency plans.
  • Coordinate with regulatory strategy leadership for global health authority interactions.
  • Oversee the authoring, review, and assembly of submission-ready regulatory dossiers.
  • Develop and track project budgets, including expenditure forecasting.

Skills

Regulatory PM
Cross-functional collaboration
Communication skills
Risk management
Budget forecasting
Attention to detail

Education

Bachelor's degree in science

Tools

Microsoft Project
Smartsheet

Job description

Ladders is seeking an Associate Director, Regulatory Project Management to lead planning and coordination of regulatory programs supporting submission readiness and post-approval activities in a global development environment.

You will partner with Regulatory Strategy, cross-functional teams, and health authorities to keep timelines aligned, manage risks, and ensure accurate dossier assembly, disciplined documentation, and sound budget forecasting to drive compliant execution.

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