Lead and manage global regulatory activities for Summit’s investigational therapy, ensuring compliance with FDA and international authorities while driving clinical development timelines.
Compensation
$168,000—$198,000 USD
Responsibilities
Provide scientific and regulatory guidance to project teams at the clinical study level
Assess, develop, and implement global regulatory strategies for ivonescimab
Independently manage regulatory activities including CTA, IND, BLA, and MAA submissions
Review and approve investigator document packages and FDA submissions
Coordinate written responses to agency queries and track regulatory commitments
Requirements
BA/BS in Biotechnology, Biological Sciences, or related field
Graduate-level degree such as MS, PhD, or PharmD
Nice to have: knowledge of Chinese
Nice to have: experience with ex-US CTAs
Nice to have: experience with ex-US health authority interactions
Support the development and successful performance of the CMC regulatory strategy for the innovative pipeline of Cell & Gene Therapies.
Locations (3)
Santa Monica, California, United States
Gaithersburg, Maryland, United States
Boston, Massachusetts, United States
Compensation
The annual base pay (or hourly rate of compensation) for this position ranges from $135,624.80 - $203,437.20 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).
Responsibilities
Interpret global regulations and guidance to identify risks and provide input for guidance to cross functional product teams.
Lead global CMC strategy for cell and gene therapies, translating pioneering science into high-quality submissions and health authority interactions to accelerate patient access.
Locations (3)
Santa Monica, California, United States
Gaithersburg, Maryland, United States
Boston, Massachusetts, United States
Compensation
The annual base salary for this position ranges from $186,232 - 279,349.
Responsibilities
Global CMC Strategy: Provide strategic guidance during all stages of product development and lead the development and implementation of global CMC regulatory strategies for cell and gene therapy programs.
Regulatory Intelligence and Risk Management: Interpret global regulations and guidance to identify risks and provide clear, actionable input to cross-functional product teams.
Own and deliver IND and global regulatory submissions end-to-end, ensuring compliant, high-quality dossiers reach health authorities on time—while driving consistency, efficiency, and operational excellence across submission activities.
Compensation
Warsaw - PL: zł144,100 - zł174,616
Responsibilities
Own and deliver IND and global regulatory submissions end-to-end
Ensure compliant, high-quality dossiers reach health authorities on time
Drive consistency, efficiency, and operational excellence across submission activities
Requirements
Bachelor’s degree (science or related field preferred)
Own and deliver IND and global regulatory submissions end-to-end, ensuring compliant, high-quality dossiers reach health authorities on time—while driving consistency, efficiency, and operational excellence across submission activities.
Compensation
Warsaw - PL: zł144,100 - zł174,616
Responsibilities
Leading coordination of submission activities across global teams
Partnering with stakeholders to define submission strategy and timelines
Managing IND and marketing application submissions from planning through to delivery
Tracking progress, identifying risks, and ensuring milestones stay on track
Executing eCTD publishing and managing submissions via HA portals
Requirements
Bachelor’s degree (science or related field preferred)
Provide medical and scientific oversight for clinical trials, serve as Medical Monitor, support protocol development, safety monitoring, data review, and business development activities for oncology/hematology studies.
Responsibilities
Provide medical and scientific input to clinical research programs
Ensure medical activities comply with GCP
Develop and review study protocols and safety plans
Provide on‑call coverage for protocol queries
Review and analyze safety data and adverse events
Requirements
Medical Degree from an accredited medical school
Nice to have: 3-5 years biopharmaceutical industry experience
Nice to have: Oncology/Hematology specialization
Nice to have: Board Certified/Eligible in Oncology
Dossier Leadership and Health Authority Engagement: Partner with stakeholders to deliver CMC components of IND, IMPD, BLA, Master Files, amendments, and annual reports.
Lifecycle Management: Manage and maintain regulatory dossiers throughout the product lifecycle.
Standards and Ways of Working: Support the development and maintenance of regulatory templates, best practices, and procedures.
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