We are seeking an experienced freelance consultant specializing in Veterinary Regulatory Affairs with a strong background in biologics and immunology.
The consultant will provide strategic and operational regulatory guidance to support the development, registration, and lifecycle management of veterinary biologic products, including vaccines, monoclonal antibodies, and immunomodulators. This role requires expertise in global veterinary regulatory frameworks such as USDA Center for Veterinary Biologics (CVB) and EMA/CVMP, and a proven track record of successful product approvals.
Key Responsibilities
* Develop, review, and submit high-quality regulatory documentation for veterinary biologics (e.g., Outline of Production, Special Outline, Product Licensing Applications, Variations).
* Provide strategic regulatory advice across development stages, including preclinical, clinical, and post-approval phases.
* Interpret and apply relevant regulatory guidance (e.g., USDA CVB, EMA CVMP, VICH) to biologics development and submission strategies.
* Collaborate cross-functionally with R&D, Quality, Manufacturing, and Clinical teams to ensure regulatory alignment.
* Support regulatory agency interactions, including preparation for meetings, responses to queries, and inspection readiness.
* Monitor evolving veterinary biologics regulations and assess implications for ongoing and future projects.
* Advise on immunological aspects of product development, including antigen selection, adjuvant use, and immunogenicity assessment.
* Ensure timely and compliant execution of regulatory submissions and lifecycle activities.
Qualifications
* Advanced degree (DVM, PhD, MSc) in Immunology, Veterinary Medicine, Biology, or a related scientific discipline.
* Minimum of 10 years of experience in veterinary regulatory affairs, with a focus on biologics.
* Demonstrated expertise in immunology as applied to veterinary product development.
* Proven success in regulatory submissions and approvals for veterinary biologics (e.g., vaccines, immunotherapies).
* Strong understanding of USDA CVB and EMA/CVMP regulatory pathways.
* Excellent written and verbal communication skills.
* Ability to work independently and manage multiple projects in a dynamic, fast-paced environment.
Preferred Background
* Prior consulting experience or direct engagement with regulatory authorities.
* Experience with novel veterinary biologics, including recombinant technologies, mAbs, or cell-based therapies.
Please contcat David Atkin for more informations
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