Senior CMC Regulatory Lead – Diagnostics

MS0230 GE Healthcare Inc.; United States; Remote; USD 106,000 - 160,000; Full time

Benefits offered by this job

401(k) plan

Tuition reimbursement

Job summary

GE HealthCare seeks a Senior Regulatory Manager to provide CMC regulatory input and strategies across development and marketed products in Pharmaceutical Diagnostics. You will lead the regulation lifecycle, ensure Module 2.3/3 dossiers, and shape submission packages with global RA teams.

Applicants should have a Bachelor's degree with 6+ years in regulated pharma/diagnostics, strong analytical skills, and experience with electronic document management and QMS. Visa sponsorship is not offered.

Qualifications

• Bachelor's degree and 6+ years of regulatory experience in pharma/diagnostics.
• Experience in a highly regulated diagnostic, pharmaceutical, or medical device industry.
• Ability to prioritize and plan deliverables to strategic goals; strong analytical skills.

Responsibilities

• Provide CMC related strategic regulatory input for assigned projects/products.
• Build submission strategy documents outlining variation types and data needs.
• Review and approve published output; ensure data collection meets market needs.
• Guide the project team in data collection and level of detail for submissions.
• Write/edit CMC submission documents/sections to support regulatory submissions.
• Maintain registration tracking information and document management standards.
• Collaborate with global and regional RA to address regulatory questions.
• Advise on regulatory impact of key brand CMC variations and provide proactive guidance.
• Support QA during audits and inspections as required.
• Stay updated on CMC guidelines.

Skills

CMC regulatory input

Regulatory strategy

Submission planning

Analytical skills

Interpersonal skills

Education

Bachelor's degree

Tools

Veeva RIM

Quality management systems

Job description

GE HealthCare seeks a Senior Regulatory Manager to provide CMC regulatory input and strategies across development and marketed products in Pharmaceutical Diagnostics. You will lead the regulation lifecycle, ensure Module 2.3/3 dossiers, and shape submission packages with global RA teams.

Applicants should have a Bachelor's degree with 6+ years in regulated pharma/diagnostics, strong analytical skills, and experience with electronic document management and QMS. Visa sponsorship is not offered.