Vice President, Regulatory Affairs

Los Angeles, CA /
Clinical /
Full-Time
/ On-site
Company Overview
Appia Bio is a preclinical stage biotech company founded in 2020 with the mission to bring innovative off-the-shelf cell therapies to cancer patients. Our novel platform can generate a broad array of allogeneic NKT and T cell types and can be engineered to address challenges in tumor microenvironments. Our goal is to discover and develop allogeneic cell therapies across a broad array of cancer indications with a scalability that increases access for patients.
Our research programs are rooted in leveraging T cell biology to generate NKT and T cell subtypes from hematopoietic stem cells. The scientific foundation of Appia Bio is underpinned by collaborative research led by Lili Yang (UCLA), David Baltimore (Caltech), and Pin Wang (USC), and further advised by a stellar scientific advisory board. The management team brings decades of experience in R&D, Technical Operations and business in the biotech industry.

Position Summary
Appia Bio is seeking a Vice President of Regulatory Affairs to establish and lead our Regulatory Affairs organization and capabilities.  The individual will oversee global regulatory strategies for our pipeline of CAR-NKT products.   Through the duties and responsibilities below, the Vice President of Regulatory Affairs will play a critical role in the development of novel allogeneic cell therapies.  The successful candidate will join a culture of intellectual rigor and collegiality that we are building at Appia.

Responsibilities

    • Establishes the Regulatory function; develops and executes the regulatory strategy
    • Provides leadership and oversight of internal staff and external regulatory consultants/CROs
    • Lead interactions with global Health Authorities
    • Lead the preparation, review, and submission of regulatory documents
    • Provides assessment of regulatory risk and develops plans for risk mitigation
    • Develop and manage regulatory timelines and budget
    • Maintain knowledge and monitor changes in regulatory guidance. Interpret external developments to inform and educate internal stakeholders
    • Develop strong relationships and communicate effectively with the Research, Technical Operations, and Clinical Development teams
    • Reports to the Chief Medical Officer

Minimum Qualifications

    • The successful candidate will be an accomplished scientist with a track record of success in translational sciences in the pharmaceutical or biotechnology industry.
    • Advanced degree in Biology or related field
    • 10+ years of regulatory affairs experience in biotech or pharmaceutical company settings
    • Deep knowledge of global drug development regulations and guidelines and demonstrated successful interactions with regulatory authorities
    • Experience in successfully building and managing a regulatory team (internal and external)
    • Highly motivated self-starter with strong presence, work ethic, and focus
    • Outstanding communication skills with the ability to build transparent and collaborative relationships across the company and with other stakeholders of the company

Preferred Qualifications

    • Oncology experience and expertise. Cell therapy or immuno-oncology preferred
Benefits
Competitive Compensation Packages | Cost Sharing for Health Insurance Premiums | Flexible Work Environment | Untracked PTO | 401(k) Retirement Savings Plan Match | Life Insurance & Disability| Awesome Culture | Challenging & Fulfilling Work | Equity Options | and more
 
The statements herein are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

Appia Bio is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.