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.

The annual base pay for this position ranges from $135K to $203K. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

# Hybrid # Cell Therapy

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.