VP / SVP Regulatory Affairs (Hayward)

Meet Life Sciences; Hayward (CA); On-site; USD 170,000 - 250,000; Full time

Job summary

A leading life sciences company is seeking a VP/SVP of Regulatory Affairs to establish and oversee global regulatory strategies for innovative cell therapies. The ideal candidate will bring extensive experience in regulatory leadership, specifically in the biotech sector, and will be responsible for ensuring compliance and driving development across multiple regulatory authorities worldwide.

Qualifications

• 15+ years in biotech / pharma; 4+ years in Cell Therapy with IND / NDA experience.
• Experience interacting with global health authorities.
• Background in regulatory strategy across early to late-stage development.

Responsibilities

• Develop and execute global regulatory strategies.
• Serve as primary liaison with regulatory agencies.
• Ensure compliance with evolving global regulations and industry standards.

Skills

Regulatory Strategy

Leadership

Collaboration

Regulatory Compliance

Knowledge of FDA guidelines

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Job description

Position Title : VP / SVP, Regulatory Affairs (FTE / permanent)

Position Summary

Seeking an experienced regulatory leader to establish and oversee global regulatory strategy for innovative cell therapies. This executive role will work closely with cross-functional teams to drive development, ensure compliance, and lead regulatory interactions worldwide.

Key Responsibilities

• Develop and execute global regulatory strategies
• Lead preparation of submissions to FDA, EMA, and other authorities
• Serve as primary liaison with regulatory agencies
• Build internal regulatory capabilities and manage external partners
• Ensure compliance with evolving global regulations and industry standards
• Support inspections, audits, and due diligence activities
• Maintain regulatory documentation and oversee electronic submissions
• Manage regulatory vendors and budgets

Qualifications

• 15+ years in biotech / pharma; 4+ years in Cell Therapy with IND / NDA experience
• Strong knowledge of FDA, EMA, and ICH guidelines
• Experience interacting with global health authorities
• Background in regulatory strategy across early to late-stage development
• Bachelor’s degree in life sciences required; advanced degree preferred
• Proven leadership and collaboration skills
• Comfortable in a dynamic, hands-on environment