Senior Manager, Regulatory Operations (Contractor)

Senior Manager, Regulatory Operations (Contractor)

Job Summary
A leading biopharmaceutical organization is seeking a seasoned Senior Manager of Regulatory Operations to support global regulatory submission processes and systems. This role will focus heavily on Regulatory Information Management (RIM) and electronic publishing, ensuring timely and compliant submissions to health authorities worldwide. The ideal candidate is a subject matter expert in Veeva RIM, with deep experience in eCTD submissions and global regulatory frameworks.

Responsibilities

• Lead planning and execution of global submissions (INDs, CTAs, NDAs, MAAs)
• Manage timelines and resources to align with regulatory strategy and program goals
• Oversee and optimize Regulatory Information Management (RIM) systems
• Support infrastructure for eCTD publishing and document templates
• Drive continuous improvement in regulatory systems and processes
• Manage regulatory publishing systems and submission archive
• Collaborate cross-functionally to ensure submission excellence

Requirements:

• 7 years of Regulatory Operations experience in biotech/pharma
• Bachelor’s degree in Life Sciences or related field
• Proven expertise in eCTD publishing and global submission management
• Strong understanding of FDA, EMA, ICH regulatory requirements
• Experience with clinical-stage programs and fast-paced environments
• Proficiency in regulatory systems such as Veeva Vault RIM, Lorenz
• Exceptional project management and collaboration skill

This is a 12 month contractor assignment