Senior Regulatory Strategy & Project Lead - Remote

Ladders; United States; Remote; USD 120,000 - 145,000; Full time

Job summary

Ladders is seeking a Senior Regulatory Affairs Consultant - Regulatory Project Manager to guide regulatory project execution across global development programs from a remote location. You will translate strategy into actionable plans with milestones, risks, and deliverables while partnering with Global Regulatory Leads and cross-functional stakeholders to drive alignment and timely decisions.

This role centers on advancing complex submissions and supporting strategic regulatory pathways in a

Qualifications

• 7+ years in pharma/biotech with regulatory management experience.
• Experience leading regulatory submissions (IND, BLA, MAA).
• Understanding of US/EU regulatory requirements; global regulations a plus.

Responsibilities

• Partner with Global Regulatory Leads to develop and execute regulatory plans.
• Translate regulatory strategy into actionable plans with milestones and risks.
• Lead execution of regulatory plans aligning with objectives.
• Identify innovative regulatory pathways aligning with global expectations.
• Drive clarity and accountability for regulatory deliverables across teams.
• Facilitate global regulatory subteam meetings focused on decision-making and risk mitigation.
• Prepare strategic dashboards/reports for senior stakeholders on progress.

Skills

Regulatory planning

Cross-functional collaboration

Regulatory strategy execution

eCTD knowledge

Regulatory reporting

Risk management

Education

BA/BS in scientific, engineering, or healthcare

MS/PharmD/PhD and/or PMP preferred

Job description

Ladders is seeking a Senior Regulatory Affairs Consultant - Regulatory Project Manager to guide regulatory project execution across global development programs from a remote location. You will translate strategy into actionable plans with milestones, risks, and deliverables while partnering with Global Regulatory Leads and cross-functional stakeholders to drive alignment and timely decisions.

This role centers on advancing complex submissions and supporting strategic regulatory pathways in a