VP Regulatory Affairs - Biologics Strategy & Compliance

SAB Biotherapeutics, Inc.; Sioux Falls (SD); On-site; USD 180,000 - 280,000; Full time

Job summary

SAB Biotherapeutics, Inc. seeks a seasoned Vice President Regulatory Affairs to lead all regulatory strategy and submissions for biologics development. The role requires directing cross-functional teams in FDA interactions, IND/BLAs/MAAs, and ensuring compliance across development and manufacturing.

With 15+ years in RA and strong leadership, you will shape regulatory policies, train staff, and partner with Quality Assurance to ensure inspection readiness.

Qualifications

• 15+ years of RA roles with increasing responsibility and experience interacting with FDA, EMA, and MHRA.
• Proven leadership experience in building and guiding high-performance teams.
• Strong knowledge of INDs, BLAs, and MAA filings and approvals.

Responsibilities

• Provide regulatory strategy and leadership across the organization to align with corporate objectives.
• Drive preparation, review, and submission of regulatory documents (INDs, BLAs, MAAs) to FDA and international authorities.
• Oversee regulatory inspections, audits, and responses to findings to ensure compliance.
• Develop and implement regulatory policies, SOPs, and staff trainings for executives and regulatory teams.
• Collaborate with Clinical Development, Manufacturing/CMC, Quality, and Medical Affairs to synchronize timelines and deliverables.

Skills

Communication skills

Leadership

Team leadership

Education

Bachelor's degree in scientific field/healthcare/regulatory discipline

Master's/PhD in relevant field

Tools

Microsoft Office

Job description

SAB Biotherapeutics, Inc. seeks a seasoned Vice President Regulatory Affairs to lead all regulatory strategy and submissions for biologics development. The role requires directing cross-functional teams in FDA interactions, IND/BLAs/MAAs, and ensuring compliance across development and manufacturing.

With 15+ years in RA and strong leadership, you will shape regulatory policies, train staff, and partner with Quality Assurance to ensure inspection readiness.