The incumbent is responsible for regulatory management to provide early guidance, review and approval of regulatory strategy, labeling and promotional material for new products. This position coordinates the format and information in the development of regulatory submissions including U.S. Veterinary Biologics Establishment License Applications, U.S. Veterinary Biological Product License Applications, New Animal Drug Applications (NADAs), and Investigational New Animal Drug submissions (INADs). The incumbent develops and conducts the training of R&D, Marketing, QA and other groups concerning regulatory issues; as well as evaluates and implements procedures pertaining to corporate regulatory activities. Additional, the incumbent is responsible for developing complex domestic and global regulatory strategies and submission in support of new and existing marketing authorizations. The incumbent will review and approve all labeling communications to trade publications, news media release, sales presentations and technical bulletins and analyze the support data for claims verification and for regulatory compliance.
Qualifications and experience include: Bachelor degree or higher in a biological science, animal science, chemistry, or a clinical field. DVM or equivalent degree and/or Ph.D. are desirable with a minimum of five years’ experience in Regulatory Affairs or FDA/USDA experience as a reviewer of product applications. Experience with NADAs and/or Veterinary Product License Applications. Understanding of 21 CFR 500-599 and/or 9 CFR 101-124. Drug and/or biologic manufacturing requirements and statistics and sampling methods.
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