Associate Director, Regulatory Affairs, CMC

Job description

Job Description Summary We are seeking a highly motivated and detail-oriented Regulatory Affairs – CMC professional with a strong background in radiopharmacy or radiopharmaceutical development. The successful candidate will support global regulatory strategy and execution for both marketed and development-stage radiopharmaceutical products involving PET and SPECT tracers. This is a cross-functional role requiring close collaboration with CMC, QA, manufacturing, and supply chain teams to ensure continued regulatory compliance and support for post-approval changes across global markets. Job Description: Roles and Responsibilities: - To be the regulatory CMC strategy point of contact for project teams and to provide CMC related regulatory input for the assigned projects/products. - Build, or provide input to, submission strategy documents by defining supplement type, data required to support submission, and submission documents required for the submission package. - Guide the project team in the project planning phase so that the correct data (and level of detail) to suit the needs of all markets is collected and submitted. - Author and review individual CMC submission documents/CMC d...