Senior Manager, Regulatory Operations

A company is looking for a Senior Manager, Regulatory Operations. Key Responsibilities Manage regulatory submission planning, publishing, and execution for global filings including INDs, CTAs, and future NDA/MAA submissions Oversee Regulatory Information Management (RIM) systems and regulatory publishing systems Support continuous improvement of regulatory systems and processes, ensuring alignment with program goals and regulatory strategy Required Qualifications Bachelor's degree in life sciences or equivalent required 7+ years of experience in Regulatory Operations within the biotech or pharmaceutical industry Deep experience with eCTD publishing and global submission management Strong knowledge of global regulatory requirements (FDA, EMA, ICH) Proficiency with regulatory systems such as Veeva Vault RIM

Created: 2026-03-05