Senior Director, Clinical Regulatory Affairs

This is a fully remote position, open to applicants in Colorado, +1 more state.

📋 Description

• Provide strategic regulatory leadership and oversight for both current and upcoming in vivo CAR-T therapy initiatives.

• Formulate and implement global regulatory strategies that support indication selection, trial design, endpoints, and program progression.

• Create registration strategies and plans, which include TPP development and evaluation, to secure regulatory approvals and achieve desired product labeling.

• Direct global regulatory submissions, encompassing IND, CTA, BLA, and MAA filings.

• Act as the primary liaison with global regulatory authorities.

• Articulate regulatory strategies, risks, mitigations, and plans to Regulatory Affairs, program teams, senior management, and external stakeholders.

• Identify, communicate, and recommend solutions to both routine and complex challenges.

• Offer regulatory guidance and advice to project teams informed by scientific data, regulatory guidelines, and historical precedents.

• Collaborate with teams in translational medicine, preclinical, clinical, CMC Regulatory, and technical disciplines.

• Keep abreast of emerging trends, competitors, and regulatory directives in the fields of cell & gene therapy as well as oncology and/or autoimmune therapeutic areas.

• Conduct regulatory research and interpret feedback, policies, guidelines, and directives from regulatory authorities.

• Partner with external program collaborators to fulfill contractual obligations and align with corporate goals.

• Provide organizational support and mentorship as the company expands its product development pipeline.

⛳️ Requirements

• For Senior Director level: A PhD, MS, or BS in a pertinent scientific discipline is required, with a minimum of 12/15/15+ years of relevant regulatory affairs experience, respectively.

• For Executive Director level: A PhD, MS, or BS in a relevant scientific field is required, with a minimum of 15/18/18+ years of relevant regulatory affairs experience, respectively.

• Strong preference for experience in Oncology, Hematology, or a related specialty.

• A proven track record of successful regulatory submissions and approvals.

• Demonstrated expertise in cell & gene therapy.

• Preferred experience with CAR-T or T-cell engaging modalities.

• Experience in in vivo gene delivery is an advantage.

• Comprehensive understanding of global regulatory requirements for both early- and late-stage development of gene and cell therapies.

• Proven capability to engage effectively with regulatory authorities.

• Willingness to travel approximately 20% for team meetings and/or regulatory engagements; some international travel may be required.

• Ability to remain seated for extended periods.

🏝️ Benefits

• Competitive medical insurance plans.

• Dental insurance plans.

• Vision insurance plans.

• 401k plan through Fidelity.

• 100% match on the first 4% deferral.

• Generous Paid Time Off policy.

• Employee commuter benefits.

• Cell phone stipend.