Shionogi Inc. is seeking a Senior Manager, Regulatory Affairs CMC to provide strategic leadership for CMC regulatory activities and ensure alignment with pipeline objectives.
You will collaborate with cross-functional teams and regulatory authorities to drive compliant submissions and timely product development. Based at our Florham Park, NJ site, this hybrid role requires 5+ years in regulatory affairs focused on CMC, strong communication, and the ability to manage INDs, NDAs, and MAAs through