Associate Director, Regulatory Project Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Create and uphold comprehensive project plans for regulatory submissions, such as IND, NDA, BLA, and MAA, along with post-approval processes.

• Ensure compliance with project scope, timelines, budgets, and quality benchmarks.

• Serve as the main regulatory liaison for timelines across Clinical, Nonclinical, CMC, Quality, and Commercial departments.

• Promote cross-functional cooperation and alignment.

• Identify, evaluate, and mitigate project risks while developing contingency plans.

• Oversee interactions with global health authorities.

• Prepare teams for agency meetings and lead the responses to regulatory inquiries.

• Manage the authoring, review, and assembly of submission-ready regulatory documents.

• Ensure the accuracy and consistency of regulatory documentation.

• Develop and monitor project budgets, forecast spending, and communicate financial performance to leadership.

• Maintain project records and documentation to ensure compliance, audit preparedness, and regulatory transparency.

• Provide leadership and stakeholders with updates on project status, risks, challenges, and key milestones.

⛳️ Requirements

• Bachelor’s degree in a scientific or related discipline.

• Over 8 years of regulatory experience in the industry.

• Strong understanding of regulatory frameworks and compliance standards in relevant sectors.

• Proficient in project management tools like Microsoft Project and Smartsheet.

• Familiarity with project management methodologies such as PMP, PRINCE2, and RAC.

• Outstanding interpersonal and communication skills.

• Analytical and problem-solving skills to interpret regulatory requirements and convert them into actionable project tasks.

• Keen attention to detail for creating accurate documentation and ensuring regulatory compliance.

🏝️ Benefits

• Company bonus based partially on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Comprehensive medical, dental, vision, and prescription drug coverage.

• Flexible benefits, including options for healthcare and/or dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Paid time off and leave of absence benefits.

• Well-being benefits, including an employee assistance program, fitness benefits, and various employee clubs and activities.

• Occasional travel opportunities.