Pharmaceuticals and Biotechnology – Regulatory Specialist at Hogan Lovells in Washington, DC

Job description

Hogan Lovells Cadwalader is an international law firm with an award-winning Life Sciences practice. Our Global Pharmaceutical and Biotechnology practice focus on supporting companies throughout the product lifecycle, including manufacturing, compliance, and post-market oversight. Our practice includes a unique blend of attorneys and technical experts with advanced scientific degrees (e.g., chemistry, microbiology, engineering, pharmaceutical sciences) as well as professionals who previously served in key roles at FDA, including investigators, compliance officers, and the Director of the Office of Compliance. Many of our attorneys previously served in FDA’s Office of the Chief Counsel and in leadership positions at FDA and the Department of Health and Human Services. We assist our clients in developing regulatory and compliance strategies, particularly in navigating Current Good Manufacturing Practice (CGMP) requirements for drugs and biologics. Our team advises on manufacturing compliance, inspection readiness, enforcement risk mitigation, and regulatory submissions related to quality systems. The position offers the opportunity to join a prestigious group addressing complex manufacturing and quality challenges in the FDA-regulated industry. Responsibilities Provides expert guidance on FDA CGMP requirements applicable to drug and biologic manufacturing (21 CFR Parts 211, 212, 600), including interpretation and implementation Advises clients on compliance with FDA regulations, inspection readiness, and post-inspection remediation strategies, including ability to conduct mock FDA inspections Assesses manufacturing facilities, quality systems, and documentation to identify compliance risks and recommend corrective and preventive actions (CAPAs) Supports clients in responding to FDA inspectional observations (Form FDA 483s), Warning Letters, regulatory meetings, and other enforcement actions Assists in developing and revising quality systems documentation, including SOPs, batch records, deviation investigations, and validation protocols Works closely with client cross-functional teams (e.g., Quality Assurance, Manufacturing, Regulatory Affairs, Engineering) to ensure compliance across operations Provides strategic advice during FDA inspections and may participate in inspection preparation and mock audits Advises on data integrity, contamination control, process validation, equipment qualification, and supplier quality management Monitors evolving FDA policies, guidance documents, and enforcement trends related to CGMP compliance Qualifications Bachelor’s, MS, or PhD degree in a relevant scientific or engineering discipline (e.g., pharmaceutical sciences, chemistry, microbiology, chemical/biomedical engineering) Minimum of 5+ years of experience as an FDA Investigator , with direct experience conducting inspections of drug and/or biologics manufacturing facilities Deep knowledge of FDA CGMP regulations, inspection processes, and enforcement actions related to pharmaceutical manufacturing Strong understanding of quality systems, including CAPA, deviation management, validation, and data integrity principles Experience reviewing manufacturing operations, laboratory controls, and quality assurance systems Familiarity with FDA regulatory submission requirements for CMC (Chemistry, Manufacturing, and Controls) sections Excellent written and verbal communication skills, including the ability to clearly explain complex regulatory requirements Ability to work collaboratively with multidisciplinary teams across different functional areas and jurisdictions Willingness and ability to travel at least 25% of the time, including international travel Work Arrangement This position may be based remotely or in a hybrid work arrangement , depending on candidate preference and proximity to Hogan Lovells Cadwalader offices Candidates must demonstrate strong attention to detail, proactive problem-solving skills, and the ability to manage multiple compl