Pharmaceuticals and Biotechnology – Regulatory Specialist

Hogan Lovells • Washington, DC

7d

About The Position

Hogan Lovells Cadwalader is an international law firm with an award-winning Life Sciences practice supporting companies throughout the product lifecycle, including manufacturing, compliance, and post-market oversight. The Global Pharmaceutical and Biotechnology practice includes attorneys and technical experts with advanced scientific degrees, as well as professionals with prior FDA experience. The team advises on regulatory and compliance strategies, particularly Current Good Manufacturing Practice (CGMP) requirements for drugs and biologics.

The Regulatory Specialist provides expert guidance on FDA CGMP requirements and advises clients on manufacturing compliance, inspection readiness, remediation, quality systems, and enforcement risk. The role supports client responses to FDA findings and regulatory actions; assesses facilities, operations, and documentation; and works with multidisciplinary client teams. The position may be based remotely or in a hybrid arrangement, depending on candidate preference and proximity to Hogan Lovells Cadwalader offices. Travel of at least 25%, including international travel, is required. Salary is commensurate with experience. The position is eligible for additional compensation, potentially including annual performance and discretionary bonuses, and firm benefits subject to plan terms and conditions.

Requirements

• Bachelor’s, MS, or PhD degree in a relevant scientific or engineering discipline, such as pharmaceutical sciences, chemistry, microbiology, or chemical or biomedical engineering.
• At least 5 years of experience as an FDA Investigator, including 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 collaborate with multidisciplinary teams across functional areas and jurisdictions.
• Willingness and ability to travel at least 25% of the time, including internationally.
• Strong attention to detail, proactive problem-solving skills, and ability to manage multiple complex projects in a fast-paced environment.

Responsibilities

• Provide expert guidance on FDA CGMP requirements applicable to drug and biologic manufacturing, including interpretation and implementation of 21 CFR Parts 211, 212, and 600.
• Advise clients on FDA regulatory compliance, inspection readiness, and post-inspection remediation strategies, including conducting mock FDA inspections.
• Assess manufacturing facilities, quality systems, and documentation to identify compliance risks and recommend corrective and preventive actions (CAPAs).
• Support client responses 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 with client cross-functional teams, including Quality Assurance, Manufacturing, Regulatory Affairs, and Engineering, to support compliance across operations.
• Provide strategic advice during FDA inspections and participate in inspection preparation and mock audits as needed.
• 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.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Paid time off
• Relocation assistance may be available
• Additional compensation may include annual performance bonuses and discretionary bonuses

What This Job Offers

• Job Type: Full-time
• Career Level: Senior