Senior Director, Clinical Regulatory Affairs

. Provide regulatory leadership and oversight for ongoing and planned in vivo CAR-T therapy programs .

Posted 9/25/2026full-timeRemote • United StatesSenior💰 $249,900 - $362,300 per yearWebsite

Key responsibilities & impact

Provide regulatory leadership and oversight for ongoing and planned in vivo CAR-T therapy programs
Develop and execute global regulatory strategies supporting indication selection, trial design, endpoints, and program advancement
Develop registration strategies and plans, including TPP development and assessment, to achieve regulatory approvals and desired product labeling
Lead global regulatory filings, including IND, CTA, BLA, and MAA submissions
Serve as the primary point of contact with global regulatory agencies
Communicate regulatory strategy, risks, mitigations, and plans to Regulatory Affairs, program teams, senior management, and external stakeholders
Identify, communicate, and propose resolutions to routine and complex issues
Provide regulatory advice and guidance to project teams based on scientific data, regulatory guidance, and precedent
Collaborate with translational medicine, preclinical, clinical, CMC Regulatory, and technical teams
Monitor emerging trends, competitors, and regulatory guidance in cell & gene therapy and oncology and/or autoimmune therapeutic areas
Conduct regulatory research and interpret regulatory authority feedback, policies, guidelines, and directives
Work with external program partners to deliver contractual obligations and corporate priorities
Provide organizational support and mentoring as the company grows its product development pipeline

What you’ll need

Senior Director level: PhD/MS/BS in a relevant scientific field required, with a minimum of 12/15/15+ years, respectively, of relevant regulatory affairs experience
Executive Director level: PhD/MS/BS in a relevant scientific field required, with a minimum of 15/18/18+ years, respectively, of relevant regulatory affairs experience
Experience in Oncology, Hematology, or related specialty strongly preferred
Successful track record of regulatory submissions and approvals
Demonstrated expertise in cell & gene therapy
Experience with CAR-T or T-cell engaging modalities preferred
Experience in in vivo gene delivery is a plus
Strong knowledge of global regulatory requirements for early- and late-stage development of gene and cell therapies
Proven ability to interact with regulatory authorities
Ability to travel approximately 20% for team meetings and/or regulatory interactions; some international travel possible
Ability to sit for prolonged periods of time

Comp & perks