Vice President, Regulatory Affairs
Cabaletta Bio
June 26, 2026
Remote friendly (All, MO)
United States
Corporate Functions
Position Description
- Remote or based out of Philadelphia, PA headquarters.
Role
Reporting to the Chief Medical Officer, the Vice President of Regulatory Affairs leads global regulatory strategy and execution for an advanced cell therapy product development program. Ensures regulatory compliance, guides interactions with health authorities (FDA, EMA, and others), and drives successful regulatory submissions and approvals. Key member of the product development team, influencing development strategy and lifecycle management for autologous cell therapy products.
Key Responsibilities
- Develop and implement global regulatory strategies across clinical development, manufacturing, and commercialization.
- Serve as primary regulatory advisor to executive leadership.
- Anticipate and interpret evolving regulatory trends in cell and gene therapy (FDA CBER guidance, EMA ATMP frameworks).
- Assess and communicate regulatory risks and propose mitigation.
- Collaborate cross-functionally (clinical/nonclinical, manufacturing, QA, medical affairs) to expedite development.
- Oversee preparation and submission of INDs, CTAS, BLAs/MAAs, and other submissions.
- Lead expedited pathway strategy (e.g., RMAT, Priority Review, PRIME), orphan designation, and pediatric study plans (US/EU) where applicable.
- Ensure compliance with GxP, ICH, and regional regulatory requirements.
- Build relationships with FDA CBER and other agencies; represent the company in key meetings.
- Ensure timely, high-quality responses to health authority inquiries (e.g., pre-BLA, Type B/C/D, scientific advice).
- Build and manage regulatory affairs/operations/writing/CMC regulatory teams; foster compliance and continuous improvement; coach team members.
Qualifications
- Advanced degree in life sciences/pharmacy or related field (PhD, PharmD, or equivalent preferred).
- 15+ years biopharma regulatory affairs experience (pre-clinical to commercialization), with 8+ years in leadership roles.
- Cell and gene therapy experience preferred.
- Proven IND and BLA submission track record (prior BLA experience required).
- Deep knowledge of FDA CBER, EMA ATMP, GxPs, and global regulatory frameworks.
- Strong leadership, strategic thinking, negotiation, and stakeholder management skills.
- Excellent communication; strong team orientation and commitment to continuous self-development.
Application Instructions
- Join via https://www.cabalettabio.com/join-our-crew.
- Remote or based out of Philadelphia, PA headquarters.
Role
Reporting to the Chief Medical Officer, the Vice President of Regulatory Affairs leads global regulatory strategy and execution for an advanced cell therapy product development program. Ensures regulatory compliance, guides interactions with health authorities (FDA, EMA, and others), and drives successful regulatory submissions and approvals. Key member of the product development team, influencing development strategy and lifecycle management for autologous cell therapy products.
Key Responsibilities
- Develop and implement global regulatory strategies across clinical development, manufacturing, and commercialization.
- Serve as primary regulatory advisor to executive leadership.
- Anticipate and interpret evolving regulatory trends in cell and gene therapy (FDA CBER guidance, EMA ATMP frameworks).
- Assess and communicate regulatory risks and propose mitigation.
- Collaborate cross-functionally (clinical/nonclinical, manufacturing, QA, medical affairs) to expedite development.
- Oversee preparation and submission of INDs, CTAS, BLAs/MAAs, and other submissions.
- Lead expedited pathway strategy (e.g., RMAT, Priority Review, PRIME), orphan designation, and pediatric study plans (US/EU) where applicable.
- Ensure compliance with GxP, ICH, and regional regulatory requirements.
- Build relationships with FDA CBER and other agencies; represent the company in key meetings.
- Ensure timely, high-quality responses to health authority inquiries (e.g., pre-BLA, Type B/C/D, scientific advice).
- Build and manage regulatory affairs/operations/writing/CMC regulatory teams; foster compliance and continuous improvement; coach team members.
Qualifications
- Advanced degree in life sciences/pharmacy or related field (PhD, PharmD, or equivalent preferred).
- 15+ years biopharma regulatory affairs experience (pre-clinical to commercialization), with 8+ years in leadership roles.
- Cell and gene therapy experience preferred.
- Proven IND and BLA submission track record (prior BLA experience required).
- Deep knowledge of FDA CBER, EMA ATMP, GxPs, and global regulatory frameworks.
- Strong leadership, strategic thinking, negotiation, and stakeholder management skills.
- Excellent communication; strong team orientation and commitment to continuous self-development.
Application Instructions
- Join via https://www.cabalettabio.com/join-our-crew.