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)
Here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve the eyesight of people worldwide. Because we’re a rapidly growing company with a dynamic, fast-paced culture, employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company.
Base Salary Range: $62,300 - $90,400
Glaukos #DareToDoMore - Regulatory Affairs Associate II (Aliso Viejo, CA)
How will you make an impact?
The Regulatory Affairs Associate, Regulatory Operations, Pharma based in Aliso Viejo, CA will work in partnership with the Regulatory Affairs, Pharma team to ensure the publication and submission of regulatory submission documents for drug-device combination products, or prescription pharmaceuticals (domestic and foreign). The Associate will be responsible for compilation and coordination of high-quality regulatory submissions for new products and for post-approval maintenance of regulatory dossiers in compliance with applicable regulations and Glaukos internal processes. The position interacts cross-functional as needed for the type and content of the regulatory submissions and may interface with regulatory agencies (e.g., US FDA and EMA) and third vendors as it relates to its job duties.