POSITION SUMMARY

The Director, CMC Regulatory Affairs reports to the Head of Regulatory Affairs and is responsible for content development, compilation, maintenance, and review of the Quality Module for regulatory submissions to support Umoja’s drug products including, DMF, IND and NDA/BLA applications, Health Authority (HA) responses, and briefing packages (including participating in/leading CMC-specific HA meetings). This role will serve as a technical regulatory leader, providing expertise to support the development of our in vivo CAR-T therapy programs. This key role is critical to ensuring that process development activities support the global regulatory strategy and eventual licensure. This position will partner with the global regulatory lead in development and execution of the overall global regulatory strategy. This role builds and relies on critical partnerships with key stakeholders to execute the strategies in alignment with business priorities. This individual also performs regulatory assessments of proposed manufacturing changes and provides guidance on regulatory expectations throughout development.

The ideal candidate will bring deep experience in cell & gene therapy and a strong track record in oncology or rheumatology drug development.

We will consider candidates at either the Director or Senior Director level based on candidate's qualifications and experiences.

CORE ACCOUNTABILITIES

Specific responsibilities include:  

• Provide technical regulatory leadership and oversight for ongoing and planned in vivo CAR-T therapy programs.
• Responsible for the development of the CMC regulatory strategy for submissions including DMFs, IND, NDA/BLA and CTD regulatory filings.
• Lead technical modules and sections of global regulatory filings (IND/CTA/BLA/MAA submissions), working with global regulatory lead to set strategy for submissions of product registration documents for health authorities worldwide.
• Interact with regulatory agencies and represent Regulatory CMC at HA meetings, including preparing subject matter experts (SMEs).
• Independently provide phase-appropriate strategic guidance/input related to current regulatory requirements and expectations for clinical trial applications and marketing applications for development projects.
• Coordinate, manage, and lead all CMC regulatory projects including management of budget, timelines, and submission planning.
• Manage and ensure compliance with all CMC regulatory reporting requirements, including annual and periodic reports.
• Independently manage and prioritize Phase 1 IND through late-stage projects.
• Identify, communicate, and propose resolutions to both routine and complex issues.
• Provide regulatory advice and guidance in the context of available and expected scientific data, regulatory guidance, and precedent to project teams to support decision making and program advancement.
• Provide regulatory expertise to business development, investor relations, and partnership discussions as needed.
• Collaborate closely with the global regulatory lead, translational medicine, preclinical, clinical, and technical teams to align overall strategy with scientific discoveries. Demonstrate ability to engage and effectively influence team members across multidisciplinary teams.
• Stay current on emerging trends, competitors, and regulatory guidance in cell & gene therapy and oncology and/or autoimmune therapeutic areas. Conduct regulatory research to assess the impact of relevant global regulations, guidance, and current regulatory environment. Provide interpretation of regulatory authority feedback, policies, guidelines, and directives.
• Work with external program partners collaboratively and effectively to deliver on contractual obligations while moving toward corporate goals and priorities.

The successful candidate will have:

• Director Level: PhD/MS/BA in a relevant scientific field of study required with a minimum of 10/12/15 years of regulatory drug development experience respectively in the biotechnology or pharmaceutical industry. Successful track record of regulatory submissions and approvals.
• Senior Director Level: PhD/MS/BA in a relevant scientific field of study required with a minimum of 12/15/15+ years of regulatory drug development experience respectively in the biotechnology or pharmaceutical industry. Successful track record of regulatory submissions and approvals.
• Demonstrated expertise in cell & gene therapy, ideally with CAR-T or T-cell engaging modalities; experience in in vivo gene delivery a plus.
• Strong knowledge of global CMC 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.

Physical Requirements:  

• Ability to travel (~20%) for team meetings and/or regulatory interactions as required. Some international travel possible.
• Ability to sit for prolonged periods of time

Director Salary Range: $206,400 - $254,900
Senior Director Salary Range: $253,000 - $312,500