Associate Director, Submissions Management - Cell Therapy
About The Position
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.
Nice To Haves
- 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.
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.
- 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.
Benefits
- Eligibility for multiple incentives
- Opportunity to receive short-term incentive bonuses
- Equity-based awards for salaried roles
- Commissions for sales roles
- Qualified retirement programs
- Paid time off (i.e., vacation, holiday, and leaves)
- Health, dental, and vision coverage
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What This Job Offers
Job Type
Full-time
Career Level
Director
