Vice President, Regulatory Affairs
On-siteAll, Catalunya, Kingdom of Spain
Job Summary
Develop and implement global regulatory strategies for cell therapy programs across clinical development, manufacturing, and commercialization. Serve as the primary regulatory advisor to executive leadership, ensuring alignment with corporate objectives and regulatory requirements. Anticipate and interpret evolving regulatory trends in cell and gene therapy, including FDA CBER guidance and EMA ATMP frameworks. Oversee content preparation and submission of INDs, CTAS, and BLAs/MAAs to regulatory agencies. Build and manage a high-performing regulatory affairs, operations, writing, and CMC regulatory team with expertise in cell and gene therapy. Lead strategy for global expedited pathways, orphan designation, and pediatric study plans. Ensure compliance of programs and submission documentation for adherence to GxP, ICH, and regional regulatory requirements throughout development and manufacturing.
Required Qualifications
- Advanced degree in life sciences, pharmacy, or related field (PhD, PharmD, or equivalent preferred)
- 15+ years of regulatory affairs experience in biopharmaceuticals from pre-clinical to commercialization
- at least 8 years in leadership roles
- Proven track record of successful IND and BLA submissions
- prior BLA experience required
- Deep knowledge of FDA CBER regulations, EMA ATMP guidelines, GxPs, and global regulatory frameworks
- Strong leadership, strategic thinking, and negotiation skills
- Excellent communication and stakeholder management abilities
- Strong team orientation and passion for continuous self-development
Desired Qualifications
- Experience in cell and gene therapy field is preferred
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.