Associate Director, Regulatory Project Management

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.