Regulatory Submissions QA Lead

FUJIFILM Biotechnologies

College Station (TX)

On-site

USD 80,000 - 115,000

Full time

14 days+

Get a reply from this employer

Your resume and cover letter, tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

FUJIFILM Diosynth Biotechnologies Texas LLC, Bryan, TX, seeks a QA Supervisor - Regulatory Affairs to lead regulatory publishing for national and regional agencies. You will coordinate data from internal teams, prepare documentation for eCTD and non-eCTD submissions, and ensure compliance with GMP/GXP, design controls, and regulatory obligations.

The role requires a Master’s or Bachelor’s with extensive regulatory experience, and involves collaboration with cross-functional teams to secure

Job description

FUJIFILM Diosynth Biotechnologies Texas LLC, Bryan, TX, seeks a QA Supervisor - Regulatory Affairs to lead regulatory publishing for national and regional agencies. You will coordinate data from internal teams, prepare documentation for eCTD and non-eCTD submissions, and ensure compliance with GMP/GXP, design controls, and regulatory obligations.

The role requires a Master’s or Bachelor’s with extensive regulatory experience, and involves collaboration with cross-functional teams to secure

Get your free, confidential resume review.

or drag and drop your file here.

Similar jobs

Similar jobs worth comparing

Regulatory QA Supervisor: eCTD Submissions Lead
Regulatory QA Supervisor: eCTD Submissions Lead

FUJIFILM • College Station (TX)

On-site
USD 80,000 - 115,000
QA Supervisor - Regulatory Affairs
QA Supervisor - Regulatory Affairs

FUJIFILM • College Station (TX)

On-site
USD 80,000 - 115,000
QA Supervisor - Regulatory Affairs
QA Supervisor - Regulatory Affairs

FUJIFILM Biotechnologies • College Station (TX)

On-site
USD 80,000 - 115,000
Senior QA Lead — Biotech Compliance & Quality
Senior QA Lead — Biotech Compliance & Quality

FUJIFILM Biotechnologies • College Station (TX)

On-site
USD 90,000 - 130,000
Senior Director, Quality Control & Compliance
Senior Director, Quality Control & Compliance

FUJIFILM Biotechnologies • College Station (TX)

On-site
USD 220,000 - 320,000
Medical, dental, vision
401(k) plan
Paid time off
+1
QA CAPA Lead - cGMP Compliance & Audit Readiness
QA CAPA Lead - cGMP Compliance & Audit Readiness

FUJIFILM • College Station (TX)

On-site
USD 65,000 - 88,230
Senior QA Analyst — Compliance & Release Leader
Senior QA Analyst — Compliance & Release Leader

Fujifilm • College Station (TX)

On-site
USD 75,000 - 95,000
Senior QA Analyst
Senior QA Analyst

FUJIFILM Biotechnologies • College Station (TX)

On-site
USD 90,000 - 130,000
Quality Assurance Specialist III
Quality Assurance Specialist III

FUJIFILM • College Station (TX)

On-site
USD 65,000 - 88,230
Regulatory Affairs Lead — FDA & EU MDR (Medical Devices)
Regulatory Affairs Lead — FDA & EU MDR (Medical Devices)

FUJIFILM • United States

Remote
USD 74,000 - 91,000
Medical, Dental, Vision
Life Insurance
401k
+1