Associate Director, Submissions Management - Cell Therapy

What You'll Do

• Lead the planning, coordination, and execution of complex global regulatory submissions across Cell Therapy development programs, including INDs, CTAs, BLAs, MAAs, amendments, supplements, variations, and lifecycle maintenance activities.

• Serve as the Submission Management lead for assigned programs, driving submission strategy discussions and ensuring alignment across Cell Therapy Translational and Safety Sciences and cross-functional teams.

• Develop and maintain integrated submission plans, timelines, milestones, and deliverables, ensuring proactive identification and mitigation of operational risks.

• Partner closely with Global Regulatory Leads and Regulatory Strategy teams to support successful health authority interactions and regulatory milestones.

• Facilitate submission planning meetings and governance activities, ensuring clear communication, accountability, and execution of deliverables.

• Coordinate content readiness activities and ensure submission components are prepared, reviewed, finalized, and published according to regulatory requirements and organizational standards.

Leadership & Strategic Impact

• Act as a trusted operational advisor to Cell Therapy Translational and Safety Sciences leaders and project teams regarding submission strategy, planning assumptions, resource requirements, risks, and execution considerations.

• Influence and drive continuous improvement initiatives related to submission management processes, technologies, metrics, and ways of working.

• Support implementation and optimization of regulatory information management systems, submission planning tools, and emerging digital capabilities.

• Promote a culture of collaboration, accountability, innovation, and operational excellence.

Essential Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Science, or a related scientific discipline.

• Significant experience within Regulatory Operations, Submission Management, Regulatory Affairs Operations, or related drug development functions in the biopharmaceutical industry.

• Demonstrated experience managing complex global regulatory submissions across multiple regions and health authorities.

• Strong understanding of regulatory submission processes, eCTD requirements, document lifecycle management, and global health authority expectations.

• Experience working in highly matrixed cross-functional environments supporting development and commercialization programs.

• Proven project leadership and stakeholder management skills.

• Strong organizational, planning, risk assessment, and problem-solving capabilities.

• Excellent communication, influencing, and collaboration skills.

• Experience utilizing regulatory information management systems and submission planning technologies.

Desirable Qualifications

• Advanced degree (MS, PharmD, PhD, or equivalent).

• Experience supporting Cell Therapy, Gene Therapy, ATMPs, biologics, or other advanced therapies.

• Experience supporting BLA and MAA submissions.

• Experience leading enterprise process improvement initiatives.

• Experience working with global regulatory authorities including FDA, EMA, MHRA, PMDA, and Health Canada.

• Line management or matrix leadership experience.