Vice President, Regulatory Affairs
Cabaletta Bio
3 months ago
Remote friendly (All, MO)
United States
Corporate Functions
Position: Vice President of Regulatory Affairs (remote or based in Philadelphia, PA)
Reporting to the Chief Medical Officer.
Responsibilities
- Develop and implement global regulatory strategies for cell therapy programs 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 (e.g., FDA CBER guidance, EMA ATMP frameworks).
- Assess and communicate regulatory risks and propose mitigation plans.
- Collaborate with cross-functional teams (clinical, nonclinical, manufacturing, QA, medical affairs) to develop and implement regulatory strategies that expedite development and maximize success.
- Oversee preparation and submission of INDs, CTAs, BLAs/MAAs, and other relevant submissions.
- Lead strategy for expedited pathways (RMAT, Priority Review, PRIME), orphan designation, and pediatric study plans (US/EU), where applicable.
- Ensure compliance with GxP, ICH, and regional regulatory requirements throughout development and manufacturing.
- Build relationships with FDA CBER and other agencies; represent the company in key regulatory meetings/negotiations.
- Ensure timely, high-quality responses to health authority inquiries (pre-BLA, Type B/C/D, scientific advice).
- Build and manage regulatory affairs/operations/writing/CMC regulatory functions; foster compliance and continuous improvement.
- Coach team members on technical skills and leadership behaviors.
Qualifications
- Advanced degree in life sciences or pharmacy (PhD, PharmD, or equivalent preferred).
- 15+ years regulatory affairs experience in biopharmaceuticals (pre-clinical to commercialization), including 8+ years in leadership roles.
- Experience in cell and gene therapy preferred.
- Proven track record of successful IND and BLA submissions (prior BLA required).
- Deep knowledge of FDA CBER, EMA ATMP, GxP, ICH, and global regulatory frameworks.
- Strong leadership, strategic thinking, negotiation, communication, and stakeholder management skills.
Benefits / Application
- Competitive benefits, PTO, and stock option plans.
- Apply via: https://www.cabalettabio.com/join-our-crew
Reporting to the Chief Medical Officer.
Responsibilities
- Develop and implement global regulatory strategies for cell therapy programs 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 (e.g., FDA CBER guidance, EMA ATMP frameworks).
- Assess and communicate regulatory risks and propose mitigation plans.
- Collaborate with cross-functional teams (clinical, nonclinical, manufacturing, QA, medical affairs) to develop and implement regulatory strategies that expedite development and maximize success.
- Oversee preparation and submission of INDs, CTAs, BLAs/MAAs, and other relevant submissions.
- Lead strategy for expedited pathways (RMAT, Priority Review, PRIME), orphan designation, and pediatric study plans (US/EU), where applicable.
- Ensure compliance with GxP, ICH, and regional regulatory requirements throughout development and manufacturing.
- Build relationships with FDA CBER and other agencies; represent the company in key regulatory meetings/negotiations.
- Ensure timely, high-quality responses to health authority inquiries (pre-BLA, Type B/C/D, scientific advice).
- Build and manage regulatory affairs/operations/writing/CMC regulatory functions; foster compliance and continuous improvement.
- Coach team members on technical skills and leadership behaviors.
Qualifications
- Advanced degree in life sciences or pharmacy (PhD, PharmD, or equivalent preferred).
- 15+ years regulatory affairs experience in biopharmaceuticals (pre-clinical to commercialization), including 8+ years in leadership roles.
- Experience in cell and gene therapy preferred.
- Proven track record of successful IND and BLA submissions (prior BLA required).
- Deep knowledge of FDA CBER, EMA ATMP, GxP, ICH, and global regulatory frameworks.
- Strong leadership, strategic thinking, negotiation, communication, and stakeholder management skills.
Benefits / Application
- Competitive benefits, PTO, and stock option plans.
- Apply via: https://www.cabalettabio.com/join-our-crew