Regulatory Project Manager

Job Summary

Providing project management leadership, the full-time remote Associate Director, Regulatory Project Management will oversee regulatory project timelines, coordinate cross-functional deliverables, and ensure compliance for submissions to health authorities globally.

Key responsibilities

• Develop and maintain integrated project plans for regulatory submissions and post-approval activities
• Act as the primary regulatory contact for timelines across various functions, fostering collaboration
• Identify and mitigate project risks while creating contingency plans to meet milestones

Required 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 and methodologies
• Excellent interpersonal skills for stakeholder engagement and decision-making