Regulatory Strategy & Submission Collaborate with global and local stakeholders to define clinical trial submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines. Assess core submission deliverables to ensure compliance, prepare and distribute global CTA dossiers, and manage data required for EU CTIS and substantial modifications. Monitor and influence the regulatory assessment process, drive negotiations with stakeholders to resolve information requests, and communicate regulatory changes to ensure ongoing compliance. Manage and track queries, commitments, and submissions with health authorities, collaborate with subject matter experts for responses, and provide periodic status updates on commitments. Continuous Improvement Initiatives Drive initiatives that promote innovation and simplify processes to enhance efficiencies for BMS teams. Contribute to the ongoing maintenance of regulatory requirements to ensure accurate and current regulatory information. Ensure consistency of Clinical Trial Applications across projects, studies, and countries, aligning with regulatory standards and best practices. Effectively communicate regulatory changes to the business to maintain compliance and support continuous improvement. Apply now and help us shape the next generation of Submissions Manager - Clinical Trials! Lead a team of direct reports managing resource and allocation and assigned projects, provide training and mentoring to new staff, and support team with development and innovation. Degree Requirements BA/BS degree, science / technology field preferred. 7+ years relevant regulatory submissions experience and people management experience. Proficient knowledge of global regulatory practices, submission guidelines and requirements. Collaborates with key stakeholders and resolves cross-functional issues independently and generates solutions by weighing risks and dependencies. Support of other RISM members sharing expertise, providing guidance and serving as a SME. Communicates effectively in English and simplifies complex topics for presentations and workshops. Applies project management methodologies and strategic thinking to define objectives, track progress, and deliver results on increasingly more complex projects. Proficient with desktop software and able to instruct others. Disclaimer: The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned.