Pharmaceuticals and Biotechnology Regulatory Specialist

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 - Bachelors, 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 complex projects in a fast-paced environment. Salary is commensurate with experience. This position is eligible for additional forms of compensation, which may include annual performance bonuses and discretionary bonuses. Employees in this role are also eligible for benefits offered by the firm, subject to applicable plan terms and conditions, which currently include medical, dental, and vision insurance; a 401(k) retirement plan; and paid time off. Additional benefits may include relocation. Please review this link for more information regarding employee benefits in the United States. Hogan Lovells Cadwalader is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, age, national origin, disability, sexual orientation, gender identity or expression, marital status, genetic information, protected Veteran status, or other factors protected by law.