Senior CMC-CVM Regulatory Affairs Consultant

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&D, Quality, Manufacturing, and Supply Chain stakeholders.

Preferred Skills

• Experience with new chemical entities (NCEs) and EPA-registered companion animal products.
• Global regulatory experience across the U.S. and rest-of-world (ROW) markets.
• Experience supporting both food animal and companion animal portfolios.
• Prior consulting or fractional leadership experience.
• Demonstrated ability to author and deliver high-quality regulatory documents for both food animal and companion animal portfolios, with a thorough understanding of the drug development process and the Center for Veterinary Medicine and the animal health industry, including regulatory requirements, guidelines, and market and policy trends.
• Strong written and oral communication skills, with the ability to build relationships and communicate effectively with internal stakeholders, external partners, and regulatory authorities.
• Highly resourceful team player with the ability to be extremely effective independently.
• Strong negotiating skills, with the ability to think creatively, develop innovative solutions, and clearly communicate those solutions to stakeholders.
• Ability to travel up to 20% as required.

Additional Notes