Regulatory Strategy and Compliance Lead

Charles River LaboratoriesWilmington, MA, USremote$130k–$150kView the original posting at Charles River Laboratories ↗

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about. Job Overview This strategic role is responsible for the regulatory strategy and compliance position of Charles River’s Biologics Testing Solutions (BTS) business unit, with specific accountability for how BTS methods and data are justified, defended, and maintained in client regulatory submissions. The role sits at the interface between BTS operations and client regulatory affairs. The individual in this role advises clients on testing strategy, method selection, comparability, and the regulatory justification required at each stage of a program; supports client filings and responses to health authority questions arising from BTS-generated data; and ensures that BTS Master Files, method validation packages, and quality system processes meet current regulatory expectations across all applicable jurisdictions. The role is also responsible for regulatory intelligence: monitoring evolving expectations for biologics safety testing, including alternative and non-animal methods, and translating those expectations into BTS internal standards, client guidance, and external positioning. Success in the role requires regulatory depth combined with the scientific credibility and client-facing capability necessary to guide sponsors through method transitions and submission-level decisions. Job Description ESSENTIAL DUTIES AND RESPONSIBILITIES: Client Regulatory Strategy and Support Serve as the primary regulatory point of contact for BTS clients on testing strategy, method selection, and the justification of BTS-generated data within regulatory submissions. Advise clients on regulatory requirements applicable to adventitious agent testing, viral safety, cell bank characterization, and lot release testing across development phases and across FDA, EMA, and other applicable jurisdictions. Support client preparation of CMC content, method justification, and comparability arguments where BTS data is relied upon; review client-facing regulatory documentation for technical and regulatory accuracy. Prepare and coordinate responses to health authority questions and information requests arising from BTS methods or data, working with client regulatory teams and BTS technical staff. Guide clients through method transitions, including the replacement of in vivo and traditional compendial methods with alternative approaches, ensuring comparability, validation, and phase-appropriate justification expectations are addressed. Participate in client meetings, technical assessments, and pre-submission discussions; represent BTS regulatory positions to client scientific, quality, and regulatory leadership. Develop and maintain client-facing regulatory guidance materials, decision tools, and technical justification templates that allow clients to act on BTS regulatory positions. Regulatory Intelligence and Positioning Monitor new and changing regulations, guidance, and compendial requirements affecting biologics safety testing, including ICH, FDA, EMA, Ph. Eur., USP, and JP, and assess the impact on BTS services and client programs. Communicate regulatory changes and resulting gaps through site and global Quality Management Reviews; ensure mitigation actions are defined, owned, and tracked to closure. Develop and maintain the BTS regulatory position on alternative methods and the reduction of animal testing; ensure internal standards and client-facing materials reflect current agency expectations. Author regulatory strategy documents, position papers, and technical justifications supporti

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