Remote Senior Regulatory Project Manager

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

Benefits offered by this job

Company bonus

Comprehensive benefits package

401(k) and pension

Job summary

Lilly, a global leader in pharmaceuticals, is seeking an Associate Director, Regulatory Project Management in a remote US role. You will lead regulatory submissions, coordinate cross-functional teams, and manage risk and budgeting to ensure timely regulatory deliverables.

Responsibilities include planning, cross-functional alignment, and communication with global health authorities, with a strong emphasis on documentation and compliance.

Qualifications

• RPMs require a blend of regulatory knowledge and project management expertise.
• 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 (Microsoft Project, Smartsheet) and methodologies (PMP, PRINCE2, RAC) for planning, tracking, and reporting.
• Excellent interpersonal and communication skills to engage stakeholders.
• Communication skills are crucial for interacting with regulatory bodies, internal management, and cross-functional teams.
• Analytical and problem-solving abilities to interpret regulatory requirements and translate them into actionable project tasks.
• Attention to detail is important for preparing accurate documentation and maintaining regulatory compliance.

Responsibilities

• Project Planning and Execution: Develop and maintain integrated regulatory submission plans and post-approval activities.
• Cross-Functional Coordination: Serve as the main regulatory contact across Clinical, Nonclinical, CMC, Quality, and Commercial.
• Risk Management: Identify and mitigate project risks with contingency plans.
• Regulatory Communication: Guide interactions with global health authorities and prepare teams for agency meetings.
• Documentation Oversight: Lead authoring and review of submission-ready dossiers.
• Budget and Resource Management: Track budgets and report financial performance.

Skills

Regulatory knowledge

Project management

Cross-functional coordination

Communication

Education

Bachelor’s degree in a scientific or related field

Tools

Microsoft Project

Smartsheet

Job description

Lilly, a global leader in pharmaceuticals, is seeking an Associate Director, Regulatory Project Management in a remote US role. You will lead regulatory submissions, coordinate cross-functional teams, and manage risk and budgeting to ensure timely regulatory deliverables.

Responsibilities include planning, cross-functional alignment, and communication with global health authorities, with a strong emphasis on documentation and compliance.