Regulatory Affairs Specialist - FDA/CDER, Combo Products

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

Benefits offered by this job

Annual Bonus Potential

Health and well-being benefits

Medical coverage

Dental coverage

Vision coverage

Life and AD&D insurance

PTO and state leaves

Educational assistance

Job summary

Becton Dickinson is seeking an experienced Regulatory Affairs professional in the United States to manage regulatory activities for combination devices and pharmaceuticals, including domestic submissions such as NDA/ANDA and labeling approvals.

The role involves coordinating with Marketing, R&D, Manufacturing, and Quality to ensure timely submissions and adherence to FDA guidance, with a focus on CDER regulatory requirements and quality systems.

Qualifications

• Minimum BS in science (Chemistry, Biology, Microbiology or engineering); Masters preferred.
• 5+ years' experience in Regulatory Affairs in Combination Products and/or Pharmaceuticals with FDA CDER experience.
• Experience with regulatory submissions to FDA and other authorities.
• Strong written and verbal communication; cross-functional collaboration.

Responsibilities

• Review CMC changes and determine regulatory reporting category per FDA guidance.
• Prepare domestic drug regulatory submissions (NDA, ANDA, PAS, CBE, etc.).
• Coordinate regulatory deliverables with Marketing, R&D, Manufacturing, Medical Affairs and Quality.
• Provide updates and strategy to Leadership for labeling and promotional materials.

Skills

Regulatory submissions

Project management

Communication

Independent work

Education

BS in science

MS preferred

Tools

MS Word

Excel

PowerPoint

Adobe Acrobat Pro

FDA databases

ERP systems

Job description

Becton Dickinson is seeking an experienced Regulatory Affairs professional in the United States to manage regulatory activities for combination devices and pharmaceuticals, including domestic submissions such as NDA/ANDA and labeling approvals.

The role involves coordinating with Marketing, R&D, Manufacturing, and Quality to ensure timely submissions and adherence to FDA guidance, with a focus on CDER regulatory requirements and quality systems.