Associate Director, Submissions Management - Cell Therapy

Responsibilities

• 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.

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.

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.

Pay

The annual base pay for this position ranges from $135,000 to $203,000. Positions offer eligibility for multiple incentives, including short-term incentive bonuses, equity-based awards for salaried roles, and commissions for sales roles.

Benefits

• Qualified retirement programs.
• Paid time off (vacation, holiday, and leaves).
• Health, dental, and vision coverage in accordance with the terms of the applicable plans.

Schedule

Hybrid