Pharmaceuticals and Biotechnology – Regulatory Specialist

The role

Hogan Lovells Cadwalader seeks a Regulatory Specialist with 5+ years of experience for its Pharmaceuticals and Biotechnology practice in Washington D.C. This role focuses on providing expert guidance on FDA CGMP requirements for drug and biologic manufacturing.

What you'll do

• Provide expert guidance on FDA CGMP requirements applicable to drug and biologic manufacturing (21 CFR Parts 211, 212, 600), including interpretation and implementation
• Advise clients on compliance with FDA regulations, inspection readiness, and post-inspection remediation strategies, including ability to conduct mock FDA inspections
• Assess manufacturing facilities, quality systems, and documentation to identify compliance risks and recommend corrective and preventive actions (CAPAs)
• Support clients in responding to FDA inspectional observations (Form FDA 483s), Warning Letters, regulatory meetings, and other enforcement actions
• Assist in developing and revising quality systems documentation, including SOPs, batch records, deviation investigations, and validation protocols
• Work closely with client cross-functional teams (e.g., Quality Assurance, Manufacturing, Regulatory Affairs, Engineering) to ensure compliance across operations
• Provide strategic advice during FDA inspections and may participate in inspection preparation and mock audits
• Advise on data integrity, contamination control, process validation, equipment qualification, and supplier quality management
• Monitor evolving FDA policies, guidance documents, and enforcement trends related to CGMP compliance

What we're looking for

Benefits