Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Regulatory Affairs Specialist - Prelicense
Location: Lenexa, KS
Job Summary and Purpose:
The position is responsible for supporting the licensure of new vaccines and new label claims for Ceva Animal Health. The Pre-license RA Specialist will work with I&D to support licensing, provide regulatory information, and prepare submissions to the USDA to support new licenses and maintain existing licenses. Other responsibilities may include, but are not limited to, reviewing protocols and reports prior to submission to USDA to ensure these studies meet the regulatory requirements, completion of regulatory documents related to specific projects and supporting the RA Senior Specialist - prelicense in preparation of submissions. The RA Specialist will work with the project leader and R&D colleagues to help ensure timelines are met for submissions to the USDA.
This position will stay up to date on new regulations to ensure license maintenance, compliance and product life cycle management guidelines are maintained.
Responsibilities and Key Duties:
Core Competencies and Attitudinal Characteristics:
Technical / Functional Competencies:
Qualifications:
Education - Bachelor's degree in Veterinary, Biology, Microbiology or other science related field. Master's degree in Veterinary, Biology, Microbiology or other science related field preferred.
Work Experience - Two or more years of experience in development, production or testing of veterinary biologics, including experience supporting veterinary biologics marketing authorizations.
Other (consider certifications, specialized knowledge and/or training, etc.) - Knowledge of USDA regulations for veterinary biological products. Knowledge of biotechnology production a plus.
Physical Requirements:
Working Conditions:
Travel Required:
This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.
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