Manager, Submission Management

Position Overview

Senior Manager – Submission Management – Clinical Trials (Poland – Warsaw). You will support 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.

Responsibilities

• 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, prepare and distribute global CTA dossiers, and manage data 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, collaborating with subject‑matter experts for responses, and provide periodic status updates on commitments.
• Lead 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.
• Lead a team of direct reports, managing resource allocation and assigned projects, providing training and mentoring, and supporting team development and innovation.

Education & Experience Requirements

• BA/BS degree in a science/technology field preferred.
• 7+ years of relevant regulatory submissions experience and people‑management experience.

Key Competency Requirements

• Proficient knowledge of global regulatory practices, submission guidelines and requirements.
• Collaborates with key stakeholders, resolves cross‑functional issues independently, and generates solutions by weighing risks and dependencies.
• Supports other RISM members by sharing expertise, providing guidance, and serving as a subject‑matter expert.
• 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 complex projects.
• Proficient with desktop software and able to instruct others.

Benefits

• Opportunity to lead and influence global submissions strategy.
• Collaborate with talented teams across the US, India, Switzerland, and beyond.
• Support continuous improvement and innovation in regulatory processes.
• Work‑from‑home option up to 50% of the time, with flexible scheduling.

Equal Employment Opportunity

Briskilys is an Equal Opportunity Employer. We encourage qualified applicants with disabilities and veterans to apply. Reasonable accommodations are provided for all applicants and employees as required by law.

R1601388: Manager, Submission Management – Warsaw, Poland.

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