Senior Manager – Regulatory Submission Compliance

Job description

The Senior Manager— CMC Regulatory Submission Compliance is responsible for aligning the regulatory landscape with country-specific requirements and supporting clinical regulatory submission activities, supply planning, and QP certification. This role leads processes and cross-functional coordination, ensuring high-quality documentation and timely approvals for clinical and commercial activities. A Typical Day: Provide support for the management of the regulatory submission form process, reviewing clinical regulatory documentation submitted to global health authorities to enable lot release for clinical trials and commercial markets. Lead and coordinate the pre-submission review process to ensure CMC regulatory documentation aligns with global requirements and country-specific expectations. Participate in cross-functional meetings to identify CMC regulatory issues related to submission documentation; ensure clear communication between IOPS and global development on submission-related risks. Develop and improve procedures and systems for review and feedback on the CMC global clinical regulatory submission packages, approvals, and status updates to improve visibility and efficiency....