Regulatory QA Supervisor: eCTD Submissions Lead

FUJIFILM Holdings America Corporation; College Station (TX); On-site; USD 80,000 - 115,000; Full time

Job summary

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

The role focuses on moderate to complex eCTD and non-eCTD submissions, regulatory intelligence, and ensuring completeness/quality of submissions, with collaboration across internal teams and stakeholders.

Qualifications

• Master’s degree or higher in science or related field and regulatory experience review/submission.
• Experience in regulatory intelligence and compliance activities.

Responsibilities

• Support electronic publishing of regulatory submissions for national/regional authorities.
• Coordinate data/documents with internal teams and external partners.
• Assist in regulatory strategy development and cross-functional collaboration.
• Maintain proficiency with regulatory requirements and FDA/notified body reviews.

Skills

Regulatory affairs

GMP/GXP

Publishing tools

eCTD publishing

CDMO regulations

Education

Master’s degree in science

Bachelor’s degree in science

Tools

Regulatory Information Systems

Publishing software

eCTD tools

Job description

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

The role focuses on moderate to complex eCTD and non-eCTD submissions, regulatory intelligence, and ensuring completeness/quality of submissions, with collaboration across internal teams and stakeholders.