Associate Director, Regulatory Project Management

Ladders; United States; Remote; USD 137,000 - 220,000; Full time

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

For our client, we are seeking a Associate Director, Regulatory Project Management to join the team of a leader in the Pharmaceuticals & Biotech space.

This role will lead the planning and coordination of regulatory programs that support submission readiness and post-approval activities across a global development environment. The Associate Director will partner closely with Regulatory Strategy, functional teams, and external health authorities to keep timelines aligned, risks managed, and deliverables moving forward. The position also plays a key role in ensuring accurate dossier assembly, disciplined documentation, and sound budget forecasting to support compliance and execution.

Location: Remote - US based candidates only, no visa sponsorship available

Compensation: $136,500 – $220,000 annually

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

Qualifications

• Bachelor's degree in a scientific or related field
• 8+ years of industry-based regulatory experience
• Strong understanding of regulatory frameworks and compliance requirements
• Proficiency in project management tools, including Microsoft Project and Smartsheet
• Excellent interpersonal and communication skills
• Analytical and problem-solving abilities
• Attention to detail for accurate documentation

Benefits

• Comprehensive benefit program including medical, dental, and vision
• 401(k) and pension eligibility
• Vacation benefits and flexible spending accounts
• Life insurance and death benefits
• Well-being benefits, including employee assistance programs and fitness benefits

Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.