Staff Regulatory Affairs Specialist - Pharma
Core
Managing regulatory activities for new and existing combination devices and/or pharmaceuticals, including healthcare antiseptic products, with direct interaction with FDA CDER.
Role type
Staff Regulatory Affairs Specialist (Pharma/Combination Products)
Builds
NDA/ANDA/PAS/CBE submissions, regulatory authority responses, and drug registration listings.
Domain
Healthcare / Pharmaceutical Regulatory Affairs
Required skills
FDA CDER interaction, NDA/ANDA/PAS/CBE submission management, regulatory strategy development, labeling and advertising compliance, CDER Direct/eDRLS system management, SPL submission via ESG, 21 CFR 210/211 knowledge, ISO 13485 knowledge, ICH guidelines knowledge, internal auditing, project management
Preferred skills
Electronic submissions experience, ERP systems experience, Masters degree, internal auditing experience
Technologies
MS Word, Excel, PowerPoint, Adobe Acrobat PRO, FDA databases, CDER Direct, eDRLS, ESG
Responsibilities
Review CMC changes and determine regulatory reporting category; Write domestic drug regulatory submissions; Determine deliverables for regulatory submissions; Work with functional representatives to review regulatory strategy; Provide updates and strategy to Leadership; Review and Approve Labeling and Advertising materials; Manage and maintain drug registrations and listings; Support SPL submission; Evaluate and prepare procedures for regulatory activities; Monitor applicable regulatory requirements; Support quality system and audits; Maintain CDER relationship; Guide team on regulations and best practices
Seniority
Staff, hands-on IC with strategic guidance