Senior Manager - Submission Management - Clinical Trials

Position Summary:

The Senior Manager, Submission Management Clinical Trials, supports end-to-end regulatory activities for assigned projects, including leading the preparation and compilation of compliant clinical trial submissions for global health authorities and supporting continuous improvement initiatives.

Position Responsibilities

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.

Team Leadership

- 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

- Degree, science/technology field preferred

Experience Requirements

- 12+ years relevant regulatory submissions experience

- 6+ years of people management experience