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)
FDA Post-Approval Regulatory Affairs Specialist
Location: Lenexa, KS
Job Summary and Purpose:
The Regulatory Affairs Specialist is responsible for managing and documenting the routine regulatory activities for Ceva’s US approved and marketed pharmaceutical products to ensure applicable regulations are followed.
Responsibilities and Key Duties:
Complete regulatory duties for marketing of approved pharmaceutical products.
Complete regulatory duties for on-going compliance of approved and marketed products.
Track and monitor critical regulatory deadline and milestones.
o Write and edit department SOPs
Core Competencies:
Technical / Functional Competencies:
Qualifications:
Education - BA/BS in a scientific discipline is preferred.
Work Experience - Basic knowledge of FDA/CVM regulations governing drug products - 21 CFR. Minimum of 2 years industry experience at an FDA-regulated facility. Demonstrated ability to learn and understand regulations and navigate through the bureaucratic processes. EPA regulatory experience (40 CFR) is a plus.
Physical Requirements:
N/A
Working Conditions:
Ability to work from home up to 60% of the time.
Travel Required:
Domestic Travel is approximately 5%.
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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