Regulatory QA Lead — Submissions & Compliance

FUJIFILM Holdings America Corporation; Bryan, Northern (TX, KY); Hybrid; USD 80,000 - 115,000; Full time

Job summary

FUJIFILM Diosynth Biotechnologies Texas LLC in Bryan, TX seeks a QA Supervisor – Regulatory Affairs to support electronic publishing of regulatory submissions and manage CMC inputs for worldwide submissions.

The role focuses on data collection from internal teams, regulatory intelligence, and ensuring regulatory compliance across FDA and other bodies, emphasizing eCTD publishing, design controls, and quality systems.

Qualifications

• Master’s degree in a related field with several years of regulatory experience.
• Experience in regulatory submissions, eCTD publishing, and CMC review.
• Knowledge of FDA regulations and global regulatory requirements.

Responsibilities

• Obtain data/documents from internal teams for regulatory submissions.
• Publish documentation to regulatory submission platforms and manage lifecycle.
• Support regulatory intelligence and compliance across submissions and projects.
• Coordinate with stakeholders to ensure timely regulatory approvals.

Skills

Regulatory affairs

GMP/GXP

Regulatory information systems

eCTD publishing

Regulatory intelligence

Education

Master's degree in Material Science

Master's degree in Biochemistry

Bachelor's degree

Tools

Regulatory Information Systems

Document management systems

eCTD publishing tools

Job description

FUJIFILM Diosynth Biotechnologies Texas LLC in Bryan, TX seeks a QA Supervisor – Regulatory Affairs to support electronic publishing of regulatory submissions and manage CMC inputs for worldwide submissions.

The role focuses on data collection from internal teams, regulatory intelligence, and ensuring regulatory compliance across FDA and other bodies, emphasizing eCTD publishing, design controls, and quality systems.