Associate Director, Regulatory Project Management

Overview

Associate Director, Regulatory Project Management provides project management leadership across Global Regulatory Affairs, serving as the central hub for regulatory projects and being accountable for regulatory project timelines and the delivery of submissions to health authorities worldwide.

What you'll do

• Develop and maintain integrated project plans for regulatory submissions (e.g., IND, NDA, BLA, MAA) and post-approval activities, ensuring adherence to scope, timelines, budgets, and quality standards.
• Act as the primary regulatory contact for timelines from functions including Clinical, Nonclinical, CMC, Quality, and Commercial, fostering collaboration and alignment.
• Identify, assess, and mitigate project risks, creating contingency plans to maintain compliance and meet milestones.
• Coordinate with Regulatory Strategy Lead to manage interactions with global health authorities, prepare teams for agency meetings, and lead responses to regulatory queries.
• Coordinate the authoring, review, and assembly of submission-ready regulatory dossiers, ensuring accuracy and consistency.
• Develop and track project budgets, forecast expenditures, and report financial performance to leadership.
• Maintain project records and documentation to support compliance, audit readiness, and regulatory transparency.
• Provide regular updates to leadership and key stakeholders on project status, risks, challenges, and milestones.

What you'll need

• Bachelor's degree in a scientific or related field.
• 8+ years of industry based regulatory experience.
• Strong understanding of regulatory frameworks and compliance requirements in relevant industries.
• Proficiency in project management tools (e.g., Microsoft Project, Smartsheet) and methodologies (PMP, PRINCE2, RAC) for planning, tracking, and reporting.
• Excellent interpersonal and communication skills to engage stakeholders, facilitate meetings, and drive decision-making.
• Communication skills crucial for interacting with regulatory bodies, internal management, and cross-functional teams, facilitating collaboration and maintaining project alignment.
• Analytical and problem-solving abilities to interpret regulatory requirements and translate them into actionable project tasks.
• Attention to detail for preparing accurate documentation and maintaining regulatory compliance.

Details

• Remote position based in the US, with occasional travel.
• Anticipated wage: $136,500 - $220,000, depending on education, experience, skills, and geographic location.