Regulatory Submissions Lead – MedTech & FDA CDER

Becton Dickinson NA; Vernon Hills (IL); On-site; USD 118,000 - 189,000; Full time

Benefits offered by this job

Annual Bonus

BD 401(k) Plan

Health and Well-being Benefits

Job summary

Becton Dickinson NA is seeking an experienced Regulatory Affairs professional to review CMC changes, prepare NDA/IND submissions, and collaborate with Marketing, R&D, Manufacturing, and Quality to align regulatory strategy. The role requires effective communication, detail orientation and project management across多 teams.

With a focus on US FDA CDER submissions and labeling approvals, you will manage registrations, CARES Act reporting, and audits, while supporting SOPs and regulatory guidelines

Qualifications

• BS in science (Chemistry, Biology, Microbiology) or engineering.
• ,

Responsibilities

• Review CMC changes and determine regulatory reporting category per FDA guidance.

Skills

Excellent organizational & comms

MS Word

Excel

PowerPoint

Adobe Acrobat Pro

FDA databases

Regulatory submissions

ERP systems

Attention to detail

Project management

Education

BS in science/engineering

MS preferred

Tools

MS Word

Excel

PowerPoint

Adobe Acrobat Pro

ERP systems

Job description

Becton Dickinson NA is seeking an experienced Regulatory Affairs professional to review CMC changes, prepare NDA/IND submissions, and collaborate with Marketing, R&D, Manufacturing, and Quality to align regulatory strategy. The role requires effective communication, detail orientation and project management across多 teams.

With a focus on US FDA CDER submissions and labeling approvals, you will manage registrations, CARES Act reporting, and audits, while supporting SOPs and regulatory guidelines