Background

TriArm Therapeutics is a clinical-stage biotechnology company that is advancing CAR T cellular therapy with novel platforms that are designed for enhanced safety, efficacy, and accessibility compared to conventional autologous CAR T therapies. Our key platform, Fast in Time (FIT^TM), involves rapid manufacturing of autologous CAR T cells, with key assets in development for solid/hematologic cancers and autoimmune diseases.

Triarm is looking for an exceptional individual with CAR T cellular therapy experience to serve as the Regulatory Affairs & Quality Assurance Lead. Depending on experience, the position title may be Senior Director or Vice President. The candidate will report directly to the Head of Clinical Development and lead key responsibilities for the Regulatory Affairs department.

Responsibilities

The Regulatory Affairs & Quality Assurance Lead will support U.S. regulatory activities related to our cellular therapy programs, including the planning, development and execution of regulatory submissions and the overseeing of CMC Regulatory and Quality Assurance activities. We are looking for a candidate who is experienced in cell therapy drug development in an biotechnology setting. This is a critical position that will play a key role in establishing and maintaining effective relationships with health authorities and cross-functional partners. The candidate will also work closely with Head of Clinical Development to develop the long-term global regulatory strategy and vision for our cell therapy products in development.

Other responsibilities for the Regulatory Affairs & Quality Assurance Lead may include the following:

• Build a regulatory team and maintain strong leadership while supporting the professional development of new hires
• Develop and implement cross-site department policies, processes and SOPs
• Interact with the FDA and other regulatory agencies to seek scientific and regulatory advice for planned phase 1 studies
• Work on all aspects of planning, creating, publishing, submitting, and archiving of regulatory submissions to health authorities
• Oversee compliance and quality activities
• Lead the implementation, validation, and operation of eCTD and electronic document management systems (e.g. Veeva) and other publishing and submissions technology projects
• Lead the training of appropriate R&D staff in the application of various standards and technologies including templates, document management practices, eCTD publishing, and other tools used within the group
• Manage regulatory budgets and vendors
• Provide regulatory leadership for due diligence activities, partnering activities, etc
• Ensure consistency, completeness, and adherence to standards for all regulatory submissions
• Ensure inspection readiness efforts for regulatory activities and files

QUALIFICATIONS:

• Bachelor's degree with a minimum of 10 years of related work experience in the biotech/pharma industry with 5 years of managerial experience developing and leading a team
• Solid track record in developing cell therapy products. Experience with breakthrough designation, RMAT, orphan designation, etc., is highly desired
• Expert knowledge of regulatory submission publishing standards and procedures, including electronic document management systems and regulatory publishing software
• Robust understanding of evolving Health Authority (HA) standards and procedures for regulatory submissions
• Demonstrated proficiencies in leading successful health meetings and interactions
• Relevant knowledge of CMC, QA, clinical and nonclinical science
• Strong project management and technical writing skills
• Strong leadership skills in leading teams, complex projects, or strategic initiatives within Regulatory and cross-functional teams
• Strong communication, strategic thinking, and problem-solving skills coupled with strong presentation skills

Salary will be competitive with the industry. This position is also eligible for bonus, benefits, and participation in Company’s stock option plan. The position will be based in person in Triarm’s office located in San Mateo, California).

Triarm Therapeutics is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Triarm is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status.