Direct Materials Regulatory Filings Principal Expert (Biopharma)

Location: Oceanside, California, United States of America

Salary: $114,700–$212,900 per year, based on the primary California location. A discretionary annual bonus may also be available.

Company

hirify.global, a member of the Roche group, is a biotechnology company focused on discovering and developing medicines for serious and life-threatening diseases.

What you will do

• Act as the technical authority and global strategist for Direct Materials Certification and Filing.
• Design and execute standardized certification and filing processes across Biologics, Synthetic Molecules, and PTC operations.
• Develop enterprise-level filing strategies and align approaches with PTR, Health Authority requirements, and global compliance standards.
• Drive modernization, technology innovation, and program implementation across PTD, PTM, PTT, PTC, and PTQ stakeholders.
• Resolve complex regulatory challenges involving virus risk, BSE/TSE, and biological-derived materials.
• Review and approve enterprise-wide compliance, technical, and scientific documents while maintaining inspection readiness.

Requirements

• BS, MS, or PhD in Science, Engineering, or Management.
• At least 8 years of experience in the pharmaceutical, biopharmaceutical, or medical device industry.
• Extensive experience with regulatory filings and material specifications.
• Expert knowledge of ICH and ISO standards, pharmaceutical GMP operations, and Health Authority regulations.
• Advanced knowledge of statistical methods, FMEA, Six Sigma, and Lean Principles.
• Experience leading high-impact teams in a global matrix environment, with strong communication, influencing, and coaching skills.

Culture & Benefits

• Benefits are available for this full-time regular position.
• Work supports global collaboration across External Quality, Procurement, PTC, QC, QA, Manufacturing, and Regulatory functions.
• hirify.global promotes an inclusive environment and is an equal opportunity employer.
• Relocation benefits are not available for this posting.