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, which encompass IND, NDA, BLA, and MAA, along with post-approval activities.

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

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

• Promote collaboration and alignment across various functions.

• Identify, evaluate, and alleviate project risks while developing contingency strategies.

• Manage interactions with global health authorities.

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

• Oversee the writing, review, and compilation of submission-ready regulatory documents.

• Guarantee the accuracy and consistency of regulatory documentation.

• Create and monitor project budgets, forecast expenses, and report financial performance to leadership.

• Preserve project records and documentation to ensure compliance, audit readiness, and regulatory transparency.

• Provide updates to leadership and stakeholders regarding project status, risks, challenges, and milestones.

⛳️ Requirements

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

• Over 8 years of regulatory experience within the industry.

• A solid understanding of regulatory frameworks and compliance obligations in pertinent industries.

• Expertise in project management tools such as Microsoft Project and Smartsheet.

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

• Outstanding interpersonal and communication skills.

• Strong analytical and problem-solving capabilities to interpret regulatory requirements and convert them into actionable project tasks.

• Exceptional attention to detail.

• Ability to juggle multiple priorities and adapt to changing regulatory demands.

🏝️ Benefits

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

• Company-sponsored 401(k) plan.

• Pension plan.

• Paid vacation benefits.

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

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

• Life insurance and death benefits.

• Time off and leave of absence provisions.

• Well-being benefits that encompass an employee assistance program, fitness perks, and employee clubs and activities.

• Occasional travel opportunities.