Virbac
Lead/Senior CMC Regulatory Scientist
Virbac Animal Health is seeking a Lead/Senior CMC Regulatory Scientist for its Regulatory Affairs Team. The role includes designing and evaluating studies to meet regulatory requirements and defining the regulatory strategy for US submissions. Key Responsibilities
Lead or oversee development of US CMC technical‑regulatory strategies for assigned projects. Prepare technical‑regulatory gap analyses and propose scenarios with risk/criticality assessment. Provide feedback on manufacturing changes to commercialized products. Write and review post‑approval submissions, US CMC technical sections, and other CMC submissions. Validate high‑risk strategies with regulatory authorities and lead meetings as needed. Ensure CVM submissions meet deadlines and negotiate timelines when required. Act as subject‑matter expert for pre‑ and post‑approval changes within Virbac. Maintain up‑to‑date records, share and archive submissions to CVM. Provide input into technical documentation, including specifications, protocols, and reports. Design VICH regulatory stability studies and monitor their implementation. Ensure delivery of stability protocols and reports in accordance with Virbac practices. Collaborate cross‑functionally and build effective relationships with internal and external stakeholders. Participate in industry working groups to help shape the regulatory landscape. Mentor junior regulatory staff and drive CMC team improvements. Support new and existing colleagues, share learnings, and improve processes. Qualifications
Bachelor’s degree or higher in a scientific field (chemistry, biology, animal science, or related field) or equivalent experience. 6–8 years (Lead) or 9+ years (Senior) diverse pharmaceutical regulatory experience, with at least 3 years in the veterinary pharmaceutical industry. Previous extensive direct interaction with the FDA; experience interacting with CVM preferred. Experience in CMC aspects of Regulatory Affairs in GMP manufacturing. Experience assembling CMC‑related submissions to regulatory authorities. Minimum of 15% travel. Strong working knowledge of current pharmaceutical regulations. Detail‑ and deadline‑oriented, capable of working independently and in a team. Excellent writing and communication skills, with proficiency in Microsoft Office and Adobe Acrobat. Ability to analyze problems, anticipate impacts, and influence others across functional and geographical boundaries. Benefits
Remote work, generous time off (13 holidays, floating holidays, vacation and sick time), 401(k) with match, life, medical, dental, and vision benefits, and more.
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Virbac Animal Health is seeking a Lead/Senior CMC Regulatory Scientist for its Regulatory Affairs Team. The role includes designing and evaluating studies to meet regulatory requirements and defining the regulatory strategy for US submissions. Key Responsibilities
Lead or oversee development of US CMC technical‑regulatory strategies for assigned projects. Prepare technical‑regulatory gap analyses and propose scenarios with risk/criticality assessment. Provide feedback on manufacturing changes to commercialized products. Write and review post‑approval submissions, US CMC technical sections, and other CMC submissions. Validate high‑risk strategies with regulatory authorities and lead meetings as needed. Ensure CVM submissions meet deadlines and negotiate timelines when required. Act as subject‑matter expert for pre‑ and post‑approval changes within Virbac. Maintain up‑to‑date records, share and archive submissions to CVM. Provide input into technical documentation, including specifications, protocols, and reports. Design VICH regulatory stability studies and monitor their implementation. Ensure delivery of stability protocols and reports in accordance with Virbac practices. Collaborate cross‑functionally and build effective relationships with internal and external stakeholders. Participate in industry working groups to help shape the regulatory landscape. Mentor junior regulatory staff and drive CMC team improvements. Support new and existing colleagues, share learnings, and improve processes. Qualifications
Bachelor’s degree or higher in a scientific field (chemistry, biology, animal science, or related field) or equivalent experience. 6–8 years (Lead) or 9+ years (Senior) diverse pharmaceutical regulatory experience, with at least 3 years in the veterinary pharmaceutical industry. Previous extensive direct interaction with the FDA; experience interacting with CVM preferred. Experience in CMC aspects of Regulatory Affairs in GMP manufacturing. Experience assembling CMC‑related submissions to regulatory authorities. Minimum of 15% travel. Strong working knowledge of current pharmaceutical regulations. Detail‑ and deadline‑oriented, capable of working independently and in a team. Excellent writing and communication skills, with proficiency in Microsoft Office and Adobe Acrobat. Ability to analyze problems, anticipate impacts, and influence others across functional and geographical boundaries. Benefits
Remote work, generous time off (13 holidays, floating holidays, vacation and sick time), 401(k) with match, life, medical, dental, and vision benefits, and more.
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