DS Inpharmatics is hiring: Senior CMC-CVM Regulatory Affairs Consultant in Phila

Product Life Group (PLG), an international Consulting group is seeking a fully remote Senior Consultant, CMC-CVM Regulatory Affairs , with deep expertise in animal health pharmaceuticals to support regulatory strategy, submissions, and lifecycle management for food and companion animal products. This role will provide strategic and hands-on CMC regulatory leadership, serving as a primary interface with FDA-CVM and supporting development programs through approval and post-approval phases. Role and Responsibilities Provide expert guidance on CMC regulatory strategy to enable early approvals and efficient regulatory pathways. Author FDA labeling and distributor labeling of prescription and over-the-counter new animal drugs, as well as new animal drugs for use in animal feeds. Advise on global development and registration strategies, including harmonization where applicable. Provide regulatory oversight and guidance for CDMOs, CMOs, and CROs. Support development programs for new chemical entities and line extensions. Author and/or review CMC technical sections, VMFs, supplements, amendments, and post-approval submissions. Prepare and support FDA-CVM Type A and Type B meetings, including briefing books and agency responses. Serve as a subject-matter expert and liaison with FDA-CVM as needed. Provide CMC input across development stages, including formulation, process development, and scale-up. Demonstrated success obtaining FDA-CVM approvals and/or USDA-CVB product licenses. Support post-approval change management, troubleshooting, and lifecycle planning. Advise on regulatory risk assessment and mitigation strategies. Provide oversight and regulatory guidance for CDMOs/CMOs, including tech transfer and compliance considerations. Collaborate with internal R In Summary: Product Life Group (PLG) is seeking a fully remote Senior Consultant, CMC-CVM Regulatory Affairs . The role will provide strategic and hands-on CMC regulatory leadership, serving as a primary interface with FDA . Author FDA labeling and distributor labeling of prescription and over-the-counter new animal drugs . En Español: Producto Life Group (PLG), un grupo de consultoría internacional está buscando un asesor senior totalmente remoto, CMC-CVM Regulatory Affairs , con una profunda experiencia en farmacéuticos para la salud animal para apoyar la estrategia reguladora, las presentaciones y el manejo del ciclo de vida de los productos alimenticios y animales acompañantes. Esta función proporcionará liderazgo regulatorio estratégico y práctico a la CMC, sirviendo como interfaz principal con FDA- CVM y apoyando programas de desarrollo a través de fases de aprobación y posaprobación. Apoyar la gestión de cambios después de la aprobación, solucionar problemas y planificar el ciclo de vida. Asesorar sobre las estrategias de evaluación del riesgo regulatorio y mitigación. Proporcionar supervisión y orientación reglamentaria para los CDMO/CMOs, incluidas consideraciones sobre transferencia tecnológica y cumplimiento. Colaborar con R interno