Regulatory Affairs Lead — FDA/Combination Products

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

Benefits offered by this job

Annual Bonus

Medical coverage

BD 401(k) Plan

Job summary

Becton, Dickinson and Company, in Illinois, seeks a Regulatory Affairs professional for combination products and pharmaceuticals. You’ll independently lead NDA/ANDA submissions and interact with FDA CDER while collaborating with R&D, Quality, Manufacturing, Medical Affairs, and Commercial teams.

The role requires 5+ years in regulatory affairs, BS in science, and experience with FDA databases. On-site work is preferred with some travel, and a strong emphasis on compliant submissions and

Qualifications

• 5+ years of Regulatory Affairs in Combination Products and/or Pharmaceuticals with FDA CDER experience.
• Experience writing NDA/ANDA/PAS/CBE submissions and regulatory responses.
• Strong project management and cross-functional collaboration skills.
• Familiarity with 21 CFR, ISO 13485, ICH guidelines and regulatory databases.

Responsibilities

• Review CMC changes and determine reporting category under FDA guidance.
• Write domestic drug regulatory submissions (NDA, ANDA, PAS, CBE, IND, etc.).
• Coordinate regulatory deliverables with Marketing, R&D, Manufacturing, QA.
• Provide updates and strategy to Leadership.
• Review labeling and promotional materials for compliance.
• Maintain drug registrations/listings (CDER Direct/eDRLS) and CARES Act reporting.
• Support SPL submissions via ESG/CDER Direct for US labeling.
• Monitor regulatory requirements and ensure compliance.

Skills

Regulatory submissions with FDA CDER

Cross-functional collaboration

Project management of regulatory subm

Communication skills

MS Word, Excel, PowerPoint, Adobe

FDA databases navigation

Education

Bachelor's degree in science

Master's degree preferred

Tools

MS Word

Excel

PowerPoint

Adobe Acrobat Pro

ERP systems

Job description

Becton, Dickinson and Company, in Illinois, seeks a Regulatory Affairs professional for combination products and pharmaceuticals. You’ll independently lead NDA/ANDA submissions and interact with FDA CDER while collaborating with R&D, Quality, Manufacturing, Medical Affairs, and Commercial teams.

The role requires 5+ years in regulatory affairs, BS in science, and experience with FDA databases. On-site work is preferred with some travel, and a strong emphasis on compliant submissions and