Senior Manager, Regulatory Operations

A company is looking for a Senior Manager, Regulatory Operations. Key Responsibilities Lead regulatory publishing and submission processes, ensuring quality and timeliness Act as the primary liaison between R&D functions for designated applications Oversee project teams and collaborate with partners to achieve submission goals Required Qualifications Bachelor's degree in Arts or Science Minimum of 6 years of regulatory operations experience with electronic submissions 7 years of professional experience overall Certification in regulatory affairs (e.g., RAPS) is a plus Prior project management and NDA/MAA experience preferred

Mar 27, 2025 - 23:47

A company is looking for a Senior Manager, Regulatory Operations. Key Responsibilities Lead regulatory publishing and submission processes, ensuring quality and timeliness Act as the primary liaison between R&D functions for designated applications Oversee project teams and collaborate with partners to achieve submission goals Required Qualifications Bachelor's degree in Arts or Science Minimum of 6 years of regulatory operations experience with electronic submissions 7 years of professional experience overall Certification in regulatory affairs (e.g., RAPS) is a plus Prior project management and NDA/MAA experience preferred