Senior Manager, Regulatory Operations

Working with the Director of Regulatory Operations, support the oversight for global regulatory submission processes, electronic publishing, and regulatory systems management, with a particular focus on Regulatory Information Management (RIM) systems. Support the drive regulatory submission excellence, process optimization, and system innovation, ensuring the timely execution of regulatory filings across multiple health authorities, including FDA, EMA, Health Canada, MHRA, and other global agencies.

Subject matter expert in Veeva RIM, with accountability for Common Technical Document (eCTD) submissions, global regulatory compliance, and document management best practices.

What you’ll do:

• Regulatory Information Management (RIM) systems management
• Regulatory Publishing systems management
• Lead and manage regulatory submission planning, publishing, and execution for global regulatory filings including INDs, CTAs, and future NDA/MAA submissions.
• Support the regulatory operations infrastructure, including eCTD publishing, document content templates, and Regulatory Information Management (RIM).
• Manage timelines and resources for all regulatory submissions; ensure alignment with program goals and regulatory strategy.
• Support the implementation and continuous improvement of regulatory systems and processes (e.g., RIM, Publishing).
• Maintain regulatory submission archives.

Requirements:

• Bachelor’s degree in life sciences or equivalent required.
• 7+ years of experience in Regulatory Operations within the biotech or pharmaceutical industry, with a focus on clinical-stage programs.
• Deep experience with eCTD publishing and global submission management (IND, CTA, BLA/NDA, MAA).
• Strong knowledge of global regulatory requirements (FDA, EMA, ICH).
• Proven experience working in a fast-paced, dynamic environment.
• Excellent project management and cross-functional collaboration skills.
• Proficiency with regulatory systems (e.g., Veeva Vault RIM, Lorenz, etc.).