Regulatory Intel Manager

Proclinical is looking for a Regulatory Intelligence Manager to support the Director of Regulatory Intelligence at a biotech company. This is a contract position. This role focuses on global monitoring and surveillance activities throughout the drug development lifecycle. You will be responsible for implementing and managing Regulatory Affairs software, handling high-priority regulatory projects, and influencing policy and regulatory decision-making processes.

Responsibilities:

Monitor and conduct surveillance activities on a global scale for the full drug development lifecycle. Implement and manage Regulatory Affairs software for reviewing agency guidance and documentation. Manage high-priority regulatory projects, including Artificial Intelligence, submission management, and new industry guidelines. Use Veeva Vault for eCTD submission document upload and consolidation of submission dossiers for regional and global filing. Understand the regulatory framework of ongoing procedures and applications in regional and global markets. Gather and provide effective MAA & CTA information from various agencies globally. Lead the collection, formatting, maintenance, and distribution of regulatory intelligence data and content. Build and maintain the Regulatory Intel SharePoint Site for report distribution. Maintain project plans and assigned responsibilities within the Regulatory Intel group. Arrange and lead cross-functional team meetings to ensure alignment and efficiency.

Key Skills and Requirements:

Proficiency in managing regulatory projects and software. Experience with Veeva Vault for eCTD submissions. Strong understanding of global regulatory frameworks and procedures. Ability to gather and analyze regulatory intelligence data. Excellent project management and organizational skills. Effective communication and leadership abilities.