Regulatory Systems Leader role at Pierre Fabre driving evolution and performance of regulatory platforms. Overseeing strategy implementation and ensuring user support.
About the role
- Senior Director overseeing regulatory submissions and strategy for CAR-T therapies at Umoja Biopharma. Driving global regulatory success and collaboration across teams in oncology.
Responsibilities
- Responsible for content development, compilation, maintenance, and review of the Nonclinical and Clinical Modules for regulatory submissions
- Independently provide regulatory leadership and oversight for ongoing and planned in vivo CAR-T therapy programs
- Develop and execute global regulatory strategies to support indication selection, trial design, and endpoints
- Lead global regulatory filings (IND/CTA/BLA/MAA submissions)
- Primary point of contact with global regulatory agencies
- Effectively communicate the regulatory strategy, risks, mitigations, and overall plans
- Identify, communicate, and propose resolutions to both routine and complex issues
- Provide regulatory advice and guidance based on scientific data and regulatory guidance
- Collaborate closely with various teams to align overall strategy with scientific discoveries
- Stay current on emerging trends, competitors, and regulatory guidance in cell & gene therapy and oncology
Requirements
- PhD/MS/BS in a relevant scientific field required with a minimum of 12/15/15+ years, respectively, of relevant experience in regulatory affairs
- Experience in Oncology, Hematology, or related specialty strongly preferred
- Successful track record of regulatory submissions and approvals
- Demonstrated expertise in cell & gene therapy, ideally with CAR-T or T-cell engaging modalities preferred
- Strong knowledge of global regulatory requirements for early- and late-stage development of gene and cell therapies
- Proven ability to interact with regulatory authorities
- Excellent communication, leadership, and cross-functional collaboration skills
- Passion for innovation and commitment to advancing transformative therapies for patients
Benefits
- Competitive Medical, Dental, and Vision plans
- 401k plan with a 100% match up to the first 4% deferral
- Generous Paid Time Off policy
- Employee commuter benefits
- Cell phone stipend
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