Biologics Regulatory Affairs Leader

SAB; Sioux Falls (SD); Hybrid; USD 150,000 - 200,000; Full time

Job summary

SAB is seeking a Vice President of Regulatory Affairs in Sioux Falls, SD. The role is responsible for ensuring compliance in Regulatory Affairs and leading the submission of documents to the FDA and international health authorities.

The incumbent will collaborate cross-functionally and manage regulatory strategies, inspections, and audits. Candidates should have 15+ years of RA experience, a relevant degree, and excellent leadership skills.

Qualifications

• 15+ years of experience in regulatory affairs with increasing responsibility.
• Experience interacting with FDA, EMA, and MHRA.
• Proven leadership in establishing INDs and approvals of BLAs.

Responsibilities

• Lead preparation and submission of regulatory documents to FDA.
• Develop regulatory strategy plans with specific deliverables.
• Manage inspections and audits by regulatory authorities.

Skills

Regulatory leadership

Communication skills

Team collaboration

Scientific knowledge

Project management

Education

Bachelors’ degree in scientific field/healthcare/regulatory discipline

Advanced degree in relevant field

Tools

Microsoft Office (Word, Excel, PowerPoint, Outlook)

Job description

SAB is seeking a Vice President of Regulatory Affairs in Sioux Falls, SD. The role is responsible for ensuring compliance in Regulatory Affairs and leading the submission of documents to the FDA and international health authorities.

The incumbent will collaborate cross-functionally and manage regulatory strategies, inspections, and audits. Candidates should have 15+ years of RA experience, a relevant degree, and excellent leadership skills.