Staff Regulatory Affairs Specialist - Pharma

Staff-level regulatory affairs role managing submissions and compliance activities for combination devices and pharmaceuticals at a major medical technology company. Requires 5+ years of pharma/combination product experience with direct FDA CDER engagement and demonstrated success leading NDA/ANDA submissions.

Responsibilities

• Review CMC changes and determine regulatory reporting categories for approved NDA/ANDA modifications
• Write and prepare domestic drug regulatory submissions including NDA, ANDA, supplements, and IND documents
• Coordinate with R&D, Quality, Manufacturing, Medical Affairs, and Commercial teams on regulatory strategy
• Manage drug registrations, listings, and CARES Act reporting via CDER Direct/eDRLS systems
• Review labeling, advertising, and promotional materials for regulatory compliance; provide leadership updates

Requirements

• Minimum 5 years regulatory affairs experience in combination products and/or pharmaceuticals
• Direct working experience with FDA CDER and submission processes
• Bachelor's degree in science (Chemistry, Biology, Microbiology, or Engineering); Master's preferred
• Knowledge of 21 CFR 210/211, 21 CFR 820, ISO 13485, and ICH guidelines
• Proficiency with MS Word, Excel, PowerPoint, Adobe Acrobat Pro, and FDA databases
• Strong project management, written/verbal communication, and cross-functional collaboration skills
• Experience with electronic submissions and ERP systems preferred